Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-04 @ 1:42 AM
Study NCT ID:
NCT03261193
Status:
TERMINATED
Last Update Posted:
2024-05-06
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111653', 'term': 'SLC22A18 protein, human'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schottnj@upmc.edu', 'phone': '412-692-4503', 'title': 'Nicholas Schott, MD', 'organization': 'UPMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time of consent up to 48-hours post-operative', 'eventGroups': [{'id': 'EG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale (VAS) Pain Score With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '1.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after surgical procedure (cesarean delivery)', 'description': 'Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Breast Feeding Success/Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'timeFrame': '24-hours post-operatively', 'description': 'Limited breastfeeding resulting from pain or opioid side effects', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was not collected during the duration of this study.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'timeFrame': '1 hour after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected at the specified timepoint for this outcome.'}, {'type': 'SECONDARY', 'title': 'First Request for Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '17.30', 'spread': '14.90', 'groupId': 'OG000'}, {'value': '17.37', 'spread': '14.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours', 'description': 'Time to first opioid dose (measured in hours)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Score 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pruritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Group 0', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Group 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Group 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Group 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '113.69', 'spread': '12.94', 'groupId': 'OG000'}, {'value': '116.21', 'spread': '12.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '16.54', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '16.07', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff', 'unitOfMeasure': 'Breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '98.4', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in % per standard of care and documented by study staff', 'unitOfMeasure': 'percentage of SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.73', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pruritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Group 0', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Group 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Group 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Group 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pruritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Group 0', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Group 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Group 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Group 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nausea/Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '82.62', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '78.86', 'spread': '15.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours post-operative', 'description': 'Standard heart rate obtained', 'unitOfMeasure': 'Heartbeats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '86.86', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '91.33', 'spread': '6.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours post-operative', 'description': 'Standard heart rate obtained', 'unitOfMeasure': 'Heartbeats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '87.00', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '86.50', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48-hours post-operative', 'description': 'Standard heart rate obtained', 'unitOfMeasure': 'Heartbeats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '109.29', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '111.00', 'spread': '11.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '117.6', 'spread': '13.15', 'groupId': 'OG000'}, {'value': '124.00', 'spread': '5.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '71.15', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '70.36', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '68.00', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '70.67', 'spread': '8.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '75.80', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '76.50', 'spread': '7.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '16.29', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff', 'unitOfMeasure': 'Breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'OG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '16.40', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '18.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff', 'unitOfMeasure': 'Breaths/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'FG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.\n\nITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline'}, {'id': 'BG001', 'title': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.\n\nITM + Bupivacaine QLB: QL plane block with local anesthesia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.80', 'spread': '4.16', 'groupId': 'BG000'}, {'value': '33.35', 'spread': '5.17', 'groupId': 'BG001'}, {'value': '32.55', 'spread': '4.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White, Caucasian (not Hispanic or Latino)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American (not Hispanic or Latino)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian (not Hispanic or Latino)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'American Indian / Alaskan Native (not Hispanic or Latino)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Declined to answer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gravidity', 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '1.67', 'groupId': 'BG000'}, {'value': '2.64', 'spread': '1.08', 'groupId': 'BG001'}, {'value': '2.79', 'spread': '1.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.80', 'groupId': 'BG000'}, {'value': '0.93', 'spread': '0.47', 'groupId': 'BG001'}, {'value': '1.10', 'spread': '0.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of births with a gestational age of 24 weeks or more', 'unitOfMeasure': 'Number of births', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-14', 'size': 840077, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-14T13:25', 'hasProtocol': True}, {'date': '2017-08-14', 'size': 134390, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-14T13:26', 'hasProtocol': False}, {'date': '2019-06-18', 'size': 312285, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_005.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-14T13:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'limited resources for recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2017-07-27', 'resultsFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) Pain Score With Movement', 'timeFrame': '24 hours after surgical procedure (cesarean delivery)', 'description': 'Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.'}], 'secondaryOutcomes': [{'measure': 'Breast Feeding Success/Quality', 'timeFrame': '24-hours post-operatively', 'description': 'Limited breastfeeding resulting from pain or opioid side effects'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'timeFrame': '1 hour after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.'}, {'measure': 'First Request for Pain Medication', 'timeFrame': 'From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours', 'description': 'Time to first opioid dose (measured in hours)'}, {'measure': 'Sedation', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.'}, {'measure': 'Pruritis', 'timeFrame': '4-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching'}, {'measure': 'Nausea/Vomiting', 'timeFrame': '4-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Respiratory Rate', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff'}, {'measure': 'Oxygen Saturation', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in % per standard of care and documented by study staff'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'timeFrame': '4 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'timeFrame': '24 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score at Rest', 'timeFrame': '48 hours after intervention', 'description': 'VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.'}, {'measure': 'Pruritis', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching'}, {'measure': 'Pruritis', 'timeFrame': '48-hours post-operative', 'description': 'Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching'}, {'measure': 'Nausea/Vomiting', 'timeFrame': '24-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment'}, {'measure': 'Nausea/Vomiting', 'timeFrame': '48-hours post-operative', 'description': 'Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment'}, {'measure': 'Heart Rate', 'timeFrame': '4-hours post-operative', 'description': 'Standard heart rate obtained'}, {'measure': 'Heart Rate', 'timeFrame': '24-hours post-operative', 'description': 'Standard heart rate obtained'}, {'measure': 'Heart Rate', 'timeFrame': '48-hours post-operative', 'description': 'Standard heart rate obtained'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '4-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in mmHG per standard of care and documented by study staff.'}, {'measure': 'Respiratory Rate', 'timeFrame': '24-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff'}, {'measure': 'Respiratory Rate', 'timeFrame': '48-hours post-operative', 'description': 'Will be measured in rate/min per standard of care and documented by study staff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quadratus lumborum block', 'post-operative pain', 'cesarean section pain', 'analgesia', 'nerve block'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.', 'detailedDescription': 'The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.\n\nThus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).\n\nInvestigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.\n\nFor each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.\n\nThe quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).\n\nThe gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cesarean planned under spinal anesthesia\n* Singleton pregnancy\n* American Society of Anesthesiologists (ASA) classification score of 2 (or less)\n* Gestational age of at least 37 weeks\n* Intention to breastfeed infant\n\nExclusion Criteria:\n\n* Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)\n* Anatomical abnormalities contraindicating spinal or QLB placement\n* Received/Conversion to general anesthesia\n* Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)\n* History of chronic pain\n* History of chronic opioid use/abuse\n* History of Subutex, methadone, other maintenance therapy'}, 'identificationModule': {'nctId': 'NCT03261193', 'acronym': 'qlcsection', 'briefTitle': 'ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'QL Block for Post-cesarean Delivery Pain', 'orgStudyIdInfo': {'id': 'PRO16120234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'ITM + Sham QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.', 'interventionNames': ['Drug: ITM + Sham QLB']}, {'type': 'EXPERIMENTAL', 'label': 'ITM + Bupivacaine QLB', 'description': 'Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.', 'interventionNames': ['Drug: ITM + Bupivacaine QLB']}], 'interventions': [{'name': 'ITM + Sham QLB', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Sham subcutaneous non-anesthetic infiltration with saline', 'armGroupLabels': ['ITM + Sham QLB']}, {'name': 'ITM + Bupivacaine QLB', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'QL plane block with local anesthesia', 'armGroupLabels': ['ITM + Bupivacaine QLB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Amy Monroe', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans to share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicholas Schott', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Nicholas Schott', 'investigatorAffiliation': 'University of Pittsburgh'}}}}