Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-26 @ 10:15 PM
Study NCT ID:
NCT03490357
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2018-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor and patient blinded to type of block that the patient receives. Outcome assessor will check dermatomal levels after surgery.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The expected cephalad dermatomal distribution of the TAP block is T10. A positive outcome is a QL block with patient anesthesia at 2 or more dermatomes higher than the TAP block. The investigators will assume that there is a 30% difference between the two blocks, which leads to between 24 and 33 patients in each arm (ideally aiming for 30 patients in each group).\n\nThe investigators have included other sample sizes should they find that there is a higher or lower percentage difference between the QL and TAP blocks.\n\nOutcome: A positive block is considered anesthesia at T8 or above and a negative block is considered analgesia below T8'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-06', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermatomal Mapping', 'timeFrame': '6 hours', 'description': 'The primary outcome of interest is the proportion of subjects reporting a positive block. This is determined by dermatomal mapping in cephalad direction in PACU within 6 hours of TAP or QL placement. A positive outcome is one where the QL block measures 2 or more dermatomal levels higher than the TAP block'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '39510803', 'type': 'DERIVED', 'citation': 'George RM, McSwain JR, Gukasov M, Wilson DA, Nitchie H, Wilson SH. Dermatomal spread in lateral quadratus lumborum blocks versus transversus abdominus plane blocks after laparoscopic colorectal surgery: a randomized clinical trial. Reg Anesth Pain Med. 2024 Nov 7:rapm-2024-105488. doi: 10.1136/rapm-2024-105488. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.', 'detailedDescription': 'The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.\n\n* Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.\n* Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.\n* Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis\n* The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.\n* The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the TAP block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon\n\n * Part of the ERAS protocol as listed by the surgeon\n * Age 18 years and older\n * Elective procedure\n\nExclusion Criteria:\n\n* • Patient inability to consent\n\n * Patient inability to communicate for data collection\n * Conversion from laparoscopic to open case\n * Local anesthetic allergy\n * Weight less than 50 kg\n * Anatomical variation making block visualization unlikely\n * Inability to cooperate with block\n * Surgery posted longer than 6 hours\n * Known preoperative substance abuse\n * Chronic opioid use \\> 3 months\n * Patient exhibits dependence on opioids Daily opioid use for pain control'}, 'identificationModule': {'nctId': 'NCT03490357', 'briefTitle': 'Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway', 'orgStudyIdInfo': {'id': 'Pro00075597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Transversus Abdominus Plane Block', 'description': 'Standardized ERAS regional nerve block', 'interventionNames': ['Procedure: Control - Transversus Abdominus Plane Block']}, {'type': 'EXPERIMENTAL', 'label': 'Quadratus Lumborum Block', 'description': 'Quadratus lumborum nerve block', 'interventionNames': ['Procedure: Quadratus Lumborum Block']}], 'interventions': [{'name': 'Control - Transversus Abdominus Plane Block', 'type': 'PROCEDURE', 'description': 'Abdominal fascial plane block - regional anesthesia', 'armGroupLabels': ['Control - Transversus Abdominus Plane Block']}, {'name': 'Quadratus Lumborum Block', 'type': 'PROCEDURE', 'description': 'Abdominal fascial plane block - regional anesthesia', 'armGroupLabels': ['Quadratus Lumborum Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Renuka M George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}