Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-04-14 @ 7:17 PM
Study NCT ID:
NCT02949518
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2016-10-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhanced Recovery After Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'soffine@hss.edu', 'phone': '212-606-1206', 'title': 'Dr. Ellen Soffin', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected during their length of stay in the hospital (which as at most up to 5 days) after surgery.', 'description': "The risks of collecting plasma for this study are similar to the risks of a routine blood draw, including - mild pain, bruising, and very rarely infection at the place of needle insertion. However, the likelihood of these risks occurring is rare, as an arterial line catheter is routinely placed in patients undergoing this class of spine surgery in order to continuously monitor the patient's hemodynamics perioperatively. The study team expected to draw samples using the pre-existing catheter.", 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Score on QoR40 Inventory.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway (ERP) for Spine', 'description': 'he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '179.4', 'spread': '13.79', 'groupId': 'OG000'}, {'value': '170.3', 'spread': '15.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 3', 'description': 'The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.7'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.8'}]}]}, {'title': 'Time to meet physical therapy goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.4'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Day 5', 'description': 'Measured in days after surgery (in half-day increments).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient did not meet physical therapy goals'}, {'type': 'SECONDARY', 'title': 'Pain Control: Opioid Consumption.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': '0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '103.3'}, {'value': '133.2', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '218.3'}]}]}, {'title': '24-48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '97.5'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after surgery', 'description': 'Measured in morphine equivalents daily.', 'unitOfMeasure': 'morphine equivalents daily', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were discharged between the 24-48 hour time mark did not have data collected.'}, {'type': 'SECONDARY', 'title': 'Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Day 1', 'description': 'Scale of 0-10, 0 being no pain, 10 being the worst pain possible', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Post-operative Oral Intake.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '7.7'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Day 1', 'description': 'Measured in hours', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-operative Nausea, Vomiting and Ileus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Nasea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ileus', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative Day 5', 'description': 'If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '5'}]}]}, {'title': 'Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '8'}]}]}, {'title': 'Postoperative Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Days 0, 1, and 3', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were discharged before Postoperative Day 3 did not have data collected.'}, {'type': 'SECONDARY', 'title': 'Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '7.9'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '14'}]}]}, {'title': 'Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.5'}]}]}, {'title': 'Postoperative Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '10.6'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '13.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Days 0, 1, and 3', 'unitOfMeasure': 'mcg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were discharged before Postoperative Day 3 did not have data collected.'}, {'type': 'SECONDARY', 'title': 'Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.7'}]}]}, {'title': 'Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.2'}]}]}, {'title': 'Postoperative Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '15.7'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '19.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Days 0, 1, and 3', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients discharged before postoperative day 3 did not have data collected.'}, {'type': 'SECONDARY', 'title': 'Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Postoperative Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '15'}]}]}, {'title': 'Postoperative Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '20'}]}]}, {'title': 'Postoperative Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '46'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Postoperative Days 0, 1, and 3', 'unitOfMeasure': 'uIU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients discharged before postoperative day 3 did not have data collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'classes': [{'title': 'Delirium/Confusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DVT/PE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)', 'description': 'Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Recovery Pathway', 'description': 'An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA Level', 'classes': [{'categories': [{'title': 'ASA I', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'ASA II', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'ASA III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA 1: A normal healthy patient. ASA 2: A patient with a mild systemic disease. ASA 3: A patient with a severe systemic disease that is not life-threatening.', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '29.4', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '28.26', 'spread': '4.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Anesthesia Time', 'classes': [{'categories': [{'measurements': [{'value': '269', 'spread': '57', 'groupId': 'BG000'}, {'value': '268.5', 'spread': '63.8', 'groupId': 'BG001'}, {'value': '268.76', 'spread': '59.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Surgery Time', 'classes': [{'categories': [{'measurements': [{'value': '183.2', 'spread': '54', 'groupId': 'BG000'}, {'value': '192.3', 'spread': '62.4', 'groupId': 'BG001'}, {'value': '187.84', 'spread': '58.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Surgery Fusion Level', 'classes': [{'categories': [{'title': 'Fusion Level I', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Fusion Level II', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Type of Surgery - either 1 Level or 2 Level Spine Fusion was done.\n\nFusion of only one motion segment of the spine (e.g. L5-S1) is referred to as a 1 level fusion. 2-level fusion may be considered for patients with severe, disabling pain that occurs at two levels of the spine (e.g. L4-L5 and L5-S1).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-04', 'size': 638640, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-22T11:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2016-10-07', 'resultsFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Score on QoR40 Inventory.', 'timeFrame': 'Postoperative Day 3', 'description': 'The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).'}], 'secondaryOutcomes': [{'measure': 'Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.', 'timeFrame': 'Postoperative Day 5', 'description': 'Measured in days after surgery (in half-day increments).'}, {'measure': 'Pain Control: Opioid Consumption.', 'timeFrame': '48 hours after surgery', 'description': 'Measured in morphine equivalents daily.'}, {'measure': 'Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1', 'timeFrame': 'Postoperative Day 1', 'description': 'Scale of 0-10, 0 being no pain, 10 being the worst pain possible'}, {'measure': 'Time to Post-operative Oral Intake.', 'timeFrame': 'Postoperative Day 1', 'description': 'Measured in hours'}, {'measure': 'Number of Participants With Post-operative Nausea, Vomiting and Ileus', 'timeFrame': 'Postoperative Day 5', 'description': 'If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge'}, {'measure': 'Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).', 'timeFrame': 'Postoperative Days 0, 1, and 3'}, {'measure': 'Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).', 'timeFrame': 'Postoperative Days 0, 1, and 3'}, {'measure': 'Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).', 'timeFrame': 'Postoperative Days 0, 1, and 3'}, {'measure': 'Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).', 'timeFrame': 'Postoperative Days 0, 1, and 3'}, {'measure': 'Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE', 'timeFrame': 'Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)', 'description': 'Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge.'}]}, 'conditionsModule': {'conditions': ['Enhanced Recovery After Surgery', 'Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient presenting for 1 or 2 level posterior lumbar fusion.\n\nExclusion Criteria:\n\n* Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).\n* Kidney disease: GFR \\<60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).\n* Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.\n* Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).\n* Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.\n* Patients whose primary or preferred language is not English.'}, 'identificationModule': {'nctId': 'NCT02949518', 'briefTitle': 'Enhanced Recovery After Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion', 'orgStudyIdInfo': {'id': '2016-617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Recovery Pathway for Spine', 'interventionNames': ['Other: Enhanced Recovery Pathway (ERP) for Spine']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Enhanced Recovery Pathway (ERP) for Spine', 'type': 'OTHER', 'description': 'The study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.', 'armGroupLabels': ['Enhanced Recovery Pathway for Spine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ellen Soffin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, NY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}