Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-03 @ 5:44 AM
Study NCT ID:
NCT03432650
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2018-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'haskinss@hss.edu', 'phone': '212-606-1036', 'title': 'Dr. Stephen Haskins', 'organization': 'Hospital for Special Surgery, Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months following surgery', 'eventGroups': [{'id': 'EG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numerical Pain Rating System (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'NRS at Rest', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'NRS with Movement', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30min after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Rating System (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'NRS at Rest', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'NRS with Movement', 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Rating System (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'NRS at Rest', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'NRS with Movement', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Rating System (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'NRS at Rest', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'NRS with Movement', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Rating System (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'NRS at Rest', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'NRS with Movement', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '90'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After Surgery to Post Operative Day 1', 'description': 'Amount of opioids taken after surgery', 'unitOfMeasure': 'oral morphine equivalent units (mg)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately post-op in OR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'Nausea PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Nausea POD1 (24hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting POD1 (24hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post Op Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients did not answer survey questions'}, {'type': 'SECONDARY', 'title': 'Antiemetic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post Op Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post Op Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Post Op Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': '2', 'groupId': 'OG000'}, {'value': '9', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': '2', 'groupId': 'OG000'}, {'value': '9', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients did not answer questionnaire.'}, {'type': 'SECONDARY', 'title': 'Patient Score on Quality of Recovery-40 (QoR40) Inventory.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'title': 'PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '107.5', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '105', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Validated QoR40 survey score. Survey questions are added up to provide a final score. Higher score is reflective of a better outcome. Minimum score is 40, maximum score is 200.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients did not answer questionnaire'}, {'type': 'SECONDARY', 'title': 'Change in Quadriceps Motor Strength on Surgical Side', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'some patients were lost to follow up'}, {'type': 'SECONDARY', 'title': 'Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Incidence of Urinary Retention in recovery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Post Op Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).\n\nBupivacaine + dexamethasone: Anesthetic that will help treat pain and sensation after hip arthroscopy\n\nUltrasound: Ultrasound will help guide the anesthesiologist in performing the nerve block'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'spread': '13', 'groupId': 'BG000'}, {'value': '36', 'spread': '12', 'groupId': 'BG001'}, {'value': '36', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '24.9', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '25', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Short Form-8 Health Questionnaire', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'spread': '4', 'groupId': 'BG000'}, {'value': '17', 'spread': '6', 'groupId': 'BG001'}, {'value': '16.4', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This questionnaire consists of 8 questions. The score for each question is 1-5. a lower score is a better outcome. maximum score is 40, minimum score is 8. scores are reported the total for all 8 questions combined.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-23', 'size': 229776, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-08T12:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2018-01-25', 'resultsFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-26', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain Rating System (NRS) Pain Scores', 'timeFrame': '30min after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.'}, {'measure': 'Numerical Pain Rating System (NRS) Pain Scores', 'timeFrame': '1 hour after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.'}, {'measure': 'Numerical Pain Rating System (NRS) Pain Scores', 'timeFrame': '2 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.'}, {'measure': 'Numerical Pain Rating System (NRS) Pain Scores', 'timeFrame': '3 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.'}, {'measure': 'Numerical Pain Rating System (NRS) Pain Scores', 'timeFrame': '24 hours after Post Anesthesia Care Unite (PACU) arrival', 'description': 'Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Opioid Use', 'timeFrame': 'After Surgery to Post Operative Day 1', 'description': 'Amount of opioids taken after surgery'}, {'measure': 'Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery', 'timeFrame': 'Immediately post-op in OR'}, {'measure': 'Number of Patients With Nausea/Vomiting', 'timeFrame': 'Up to Post Op Day 1'}, {'measure': 'Antiemetic Use', 'timeFrame': 'Up to Post Op Day 1'}, {'measure': 'Number of Participants With Hospital Admission', 'timeFrame': 'Up to Post Op Day 1'}, {'measure': 'Patient Satisfaction With Post Op Pain Control', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied'}, {'measure': 'Patient Score on Quality of Recovery-40 (QoR40) Inventory.', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Validated QoR40 survey score. Survey questions are added up to provide a final score. Higher score is reflective of a better outcome. Minimum score is 40, maximum score is 200.'}, {'measure': 'Change in Quadriceps Motor Strength on Surgical Side', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength'}, {'measure': 'Urinary Retention', 'timeFrame': 'Up to Post Op Day 1', 'description': 'Incidence of Urinary Retention in recovery'}, {'measure': 'Incidence of Hypotension', 'timeFrame': 'Up to Post Op Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Disease']}, 'descriptionModule': {'briefSummary': 'Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for hip arthroscopy\n* Ability to follow study protocol\n* English Speaking\n\nExclusion Criteria:\n\n* Hepatic or renal insufficiency\n* Younger than 18 years old and older than 80\n* Allergy or intolerance to one of the study medications\n* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)\n* Chronic opioid use (daily opioids use for longer than 3 months)\n* Patients contraindicated to undergo a spinal anesthetic\n* Non English Speakers'}, 'identificationModule': {'nctId': 'NCT03432650', 'briefTitle': 'Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018-0647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLB Block + Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.\n\nPatients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).', 'interventionNames': ['Drug: Bupivacaine + dexamethasone', 'Device: Ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given.'}], 'interventions': [{'name': 'Bupivacaine + dexamethasone', 'type': 'DRUG', 'description': 'Anesthetic that will help treat pain and sensation after hip arthroscopy', 'armGroupLabels': ['QLB Block + Standard of Care']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound will help guide the anesthesiologist in performing the nerve block', 'armGroupLabels': ['QLB Block + Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital of Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stephen Haskins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}