Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-26 @ 10:09 AM
Study NCT ID:
NCT03726268
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Sponsor:
Organization:
Raw JSON
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Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 29, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 16, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'COVID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal ECG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bladder spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'intraoperative decrease in compliance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mouse bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'substance induced psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'intraoperative bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RUE weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'alcohol intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bladder defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bloody nasal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'convulsive-like movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diverticulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'eyelid swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hand injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heart palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heart racing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'levator spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'non-epileptic seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seizure-like activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'shoulder injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ventilatory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'wound dressing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'admission to behavioral facility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bladder spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'colovesicular fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NSTEMI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-operative Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vagal response to laryngoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cesarean delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hemorrhagic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'spontaneous labor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'OG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '15.50', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '11.60', 'groupId': 'OG001'}, {'value': '6.18', 'spread': '8.40', 'groupId': 'OG002'}, {'value': '6.67', 'spread': '10.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.970', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.631', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 30 days', 'description': 'Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects.', 'unitOfMeasure': 'tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Intraoperative Non-methadone Opioid Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'OG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '23.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '12.7', 'upperLimit': '24.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 12 hours', 'description': 'Based on hospital record.', 'unitOfMeasure': 'Milligram Morphine Equivalent (MME)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Post Anesthesia Care Unit (PACU) Opioid Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'OG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.004', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 2 hours', 'description': 'Based on hospital record.', 'unitOfMeasure': 'Milligram Morphine Equivalent (MME)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Hospital Non-methadone Opioid Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'OG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '80'}, {'value': '128', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '185'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '68', 'groupId': 'OG003', 'lowerLimit': '50', 'upperLimit': '97'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Start of surgery to hospital discharge, up to 2 days', 'description': 'Based on hospital record.', 'unitOfMeasure': 'Milligram Morphine Equivalent (MME)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total 7-day Post-PACU Discharge Home Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'OG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'OG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.50', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '8.70', 'groupId': 'OG001'}, {'value': '4.96', 'spread': '5.80', 'groupId': 'OG002'}, {'value': '5.45', 'spread': '7.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.531', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 days post-PACU discharge', 'description': 'Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects.', 'unitOfMeasure': 'tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'FG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'FG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'FG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '205'}, {'groupId': 'FG003', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}, {'value': '734', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Short-stay, IV Methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'BG001', 'title': 'Short-stay, IV Short-acting Opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'BG002', 'title': 'Same-day, IV Methadone', 'description': 'Intraoperative and post-operative IV methadone\n\nMethadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.'}, {'id': 'BG003', 'title': 'Same-day, IV Short-acting Opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion\n\nFentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nHydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nMorphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).\n\nSufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '41.6', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '44.6', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '43.6', 'spread': '12.0', 'groupId': 'BG003'}, {'value': '43.0', 'spread': '12.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '477', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '257', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}, {'value': '669', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}, {'value': '559', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}, {'value': '734', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-18', 'size': 447207, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-30T10:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 907}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2018-10-29', 'resultsFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-06', 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)', 'timeFrame': 'Approximately 30 days', 'description': 'Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects.'}], 'secondaryOutcomes': [{'measure': 'Total Intraoperative Non-methadone Opioid Administration', 'timeFrame': 'Approximately 12 hours', 'description': 'Based on hospital record.'}, {'measure': 'Total Post Anesthesia Care Unit (PACU) Opioid Administration', 'timeFrame': 'Approximately 2 hours', 'description': 'Based on hospital record.'}, {'measure': 'Total Hospital Non-methadone Opioid Administration', 'timeFrame': 'Start of surgery to hospital discharge, up to 2 days', 'description': 'Based on hospital record.'}, {'measure': 'Total 7-day Post-PACU Discharge Home Opioid Use', 'timeFrame': 'Up to 7 days post-PACU discharge', 'description': 'Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).', 'detailedDescription': 'This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day discharge surgery (compare short-duration vs long-duration opioid).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of \\< 24 hours\n* Signed, written, informed consent\n\nExclusion Criteria\n\n* History of liver or kidney disease.\n* Females who are pregnant or nursing.\n* Chronic opioid use (e.g. preoperative daily use of methadone, fentanyl transdermal patches, or ≥ 3 oxycodone pills)'}, 'identificationModule': {'nctId': 'NCT03726268', 'acronym': 'OSPREy', 'briefTitle': 'Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)', 'orgStudyIdInfo': {'id': 'Pro00089977'}, 'secondaryIdInfos': [{'id': '1R01DA042985-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA042985-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short-stay, IV methadone', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV methadone', 'interventionNames': ['Drug: Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short-stay, IV short-acting opioids', 'description': 'Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion', 'interventionNames': ['Drug: Fentanyl', 'Drug: Hydromorphone', 'Drug: Morphine', 'Drug: Sufentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Same-day, IV methadone', 'description': 'Intraoperative and post-operative IV methadone', 'interventionNames': ['Drug: Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Same-day, IV short-acting opioids', 'description': 'Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion', 'interventionNames': ['Drug: Fentanyl', 'Drug: Hydromorphone', 'Drug: Morphine', 'Drug: Sufentanil']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.', 'armGroupLabels': ['Same-day, IV methadone', 'Short-stay, IV methadone']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).', 'armGroupLabels': ['Same-day, IV short-acting opioids', 'Short-stay, IV short-acting opioids']}, {'name': 'Hydromorphone', 'type': 'DRUG', 'description': 'Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).', 'armGroupLabels': ['Same-day, IV short-acting opioids', 'Short-stay, IV short-acting opioids']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).', 'armGroupLabels': ['Same-day, IV short-acting opioids', 'Short-stay, IV short-acting opioids']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).', 'armGroupLabels': ['Same-day, IV short-acting opioids', 'Short-stay, IV short-acting opioids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Evan Kharasch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}