Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04397458
Status:
WITHDRAWN
Last Update Posted:
2023-11-03
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19 pandemic and competing study that took precedence', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '48 hours after intervention'}], 'secondaryOutcomes': [{'measure': 'Amount of opioids used', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)'}, {'measure': 'Amount of opioids used', 'timeFrame': '6 hours after intervention'}, {'measure': 'Amount of opioids used', 'timeFrame': '12 hours after intervention'}, {'measure': 'Amount of opioids used', 'timeFrame': '24 hours after intervention'}, {'measure': 'Amount of opioids used', 'timeFrame': '48 hours after intervention'}, {'measure': 'Time from quadratus lumborum block until first opioid request', 'timeFrame': 'from time of intervention until time of first opioid request (up to 48 hours)'}, {'measure': 'Pain as measured by an 11-point verbal pain score (at rest)', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (with movement)', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (at rest)', 'timeFrame': '6 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (with movement)', 'timeFrame': '6 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (at rest)', 'timeFrame': '12 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (with movement)', 'timeFrame': '12 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (at rest)', 'timeFrame': '24 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (with movement)', 'timeFrame': '24 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (at rest)', 'timeFrame': '48 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Pain as measured by an 11-point verbal pain score (with movement)', 'timeFrame': '48 hours after intervention', 'description': 'The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.'}, {'measure': 'Nausea as measured by a 3-point scale', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Nausea as measured by a 3-point scale', 'timeFrame': '6 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Nausea as measured by a 3-point scale', 'timeFrame': '12 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Nausea, pruritus and sedation as measured by a 3-point scale', 'timeFrame': '24 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Nausea as measured by a 3-point scale', 'timeFrame': '48 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Pruritus as measured by a 3-point scale', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Pruritus as measured by a 3-point scale', 'timeFrame': '6 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Pruritus as measured by a 3-point scale', 'timeFrame': '12 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Pruritus as measured by a 3-point scale', 'timeFrame': '24 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Pruritus as measured by a 3-point scale', 'timeFrame': '48 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Sedation as measured by a 3-point scale', 'timeFrame': 'at the time of intervention (one day following cesarean delivery)', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Sedation as measured by a 3-point scale', 'timeFrame': '6 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Sedation as measured by a 3-point scale', 'timeFrame': '12 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Sedation as measured by a 3-point scale', 'timeFrame': '24 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Sedation as measured by a 3-point scale', 'timeFrame': '48 hours after intervention', 'description': 'This is measured categorically as none, mild, or moderate-severe.'}, {'measure': 'Patient satisfaction as measured by the 5-point Likert scale', 'timeFrame': '48 hours after intervention', 'description': 'The 5-point scale ranges from extremely satisfied to not satisfied.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quadratus lumborum block', 'bupivacaine', 'cesarean delivery', 'c-section', 'intrathecal morphine', 'post-operative pain', 'post-cesarean analgesia'], 'conditions': ['Morphine', 'Analgesics', 'Analgesics, Opioid', 'Peripheral Nervous System Agents']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective or non-elective cesarean delivery on prior day\n* pain scores \\>5/10\n\nExclusion Criteria:\n\n* BMI \\>40\n* obstructive sleep apnea\n* drug abuse\n* chronic pain\n* chronic opioid use\n* abdominal surgeries other than cesarean delivery\n* contraindications to neuraxial or regional anesthesia\n* received general anesthesia or did not receive neuraxial morphine for cesarean delivery'}, 'identificationModule': {'nctId': 'NCT04397458', 'briefTitle': 'Rescue Quadratus Lumborum Blocks for Post-cesarean Pain', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Rescue Quadratus Lumborum Blocks for Post-cesarean Pain', 'orgStudyIdInfo': {'id': 'HSC-MS-20-0124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Control', 'description': '20 milliliters (mL) 0.9% saline on each side', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Quadratus Lumborum Block', 'description': '20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'description': '0.9% saline on each side', 'armGroupLabels': ['Sham Control']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': '0.25% bupivacaine (50mg) on each side', 'armGroupLabels': ['Quadratus Lumborum Block']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '3mg preservative-free dexamethasone on each side', 'armGroupLabels': ['Quadratus Lumborum Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Linden Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maya Suresh', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}