Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 12:27 AM
Study NCT ID:
NCT07166250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Quadratus Lumborum Block and Retrolaminar Block on Postoperative Pain in Lumbar Disc Herniation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm randomized controlled trial comparing quadratus lumborum block and retrolaminar block in patients undergoing lumbar disc herniation surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain intensity (NRS score)', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Pain intensity will be assessed using the Numerical Rating Scale (0-10) at rest and during movement.'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '24 hours after surgery', 'description': 'Total amount of opioid analgesics (morphine equivalent) administered in the first 24 hours postoperatively.'}, {'measure': 'Time to first analgesic request', 'timeFrame': '24 hours after surgery', 'description': 'Time interval between the end of surgery and the first request for additional analgesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadratus Lumborum Block', 'Retrolaminar Block', 'Spine Surgery Analgesia', 'Opioid Consumption'], 'conditions': ['Lumbar Disc Herniation', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the analgesic efficacy of quadratus lumborum block (QLB) and retrolaminar block (RLB) in patients undergoing lumbar disc herniation surgery. Both regional anesthesia techniques are increasingly used for postoperative pain management, but there is limited evidence directly comparing their effectiveness. The primary outcome is the postoperative pain score, while secondary outcomes include opioid consumption and patient satisfaction.', 'detailedDescription': 'Effective postoperative pain management is essential in patients undergoing lumbar disc herniation surgery. Regional anesthesia techniques, such as quadratus lumborum block (QLB) and retrolaminar block (RLB), have been increasingly used as alternatives or adjuncts to systemic analgesics. QLB provides analgesia by targeting the thoracolumbar fascia and spreading to the paravertebral space, whereas RLB is considered a simpler and potentially safer approach with similar analgesic potential.\n\nThis randomized controlled clinical trial is designed to compare the efficacy and safety of QLB and RLB for postoperative pain control. Adult patients scheduled for elective lumbar disc herniation surgery under general anesthesia will be randomized into two groups. One group will receive ultrasound-guided QLB, and the other group will receive ultrasound-guided RLB before surgical incision.\n\nThe primary outcome is postoperative pain intensity measured using a numerical rating scale (NRS) at multiple time intervals within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, time to first analgesic request, incidence of block-related complications, and overall patient satisfaction. The results of this study are expected to provide evidence for the optimal regional technique for postoperative analgesia in lumbar spine surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18-65 years American Society of Anesthesiologists (ASA) physical status I-II-III Scheduled for elective lumbar disc herniation surgery under general anesthesia Willing to participate and provide written informed consent Patients scheduled for elective lumbar disc herniation surgery\n\nExclusion Criteria:\n\nPatients requiring emergency surgery ASA physical status classification IV-V Known coagulopathy Ongoing anticoagulant therapy History of allergy to local anesthetics Localized infection at the block injection site Presence of spinal, paraspinal, or regional deformities at the block area Inability to understand or use the verbal pain rating scale Chronic use of analgesic medications'}, 'identificationModule': {'nctId': 'NCT07166250', 'briefTitle': 'Comparison of the Effects of Quadratus Lumborum Block and Retrolaminar Block on Postoperative Pain in Lumbar Disc Herniation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of the Effects of Quadratus Lumborum Block and Retrolaminar Block on Postoperative Pain in Lumbar Disc Herniation Surgery', 'orgStudyIdInfo': {'id': 'KANDEMIR-QLB-O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadratus Lumborum Block', 'description': 'Patients randomized to this group will receive an ultrasound-guided quadratus lumborum block (QLB) with local anesthetic injection before surgical incision for postoperative pain management.', 'interventionNames': ['Procedure: Quadratus Lumborum Block']}, {'type': 'EXPERIMENTAL', 'label': 'Retrolaminar Block', 'description': 'Patients randomized to this group will receive an ultrasound-guided retrolaminar block (RLB) with local anesthetic injection before surgical incision for postoperative pain management.', 'interventionNames': ['Procedure: Retrolaminar Block']}], 'interventions': [{'name': 'Quadratus Lumborum Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided quadratus lumborum block performed preoperatively using local anesthetic injection at the thoracolumbar fascia for postoperative analgesia in lumbar disc herniation surgery.', 'armGroupLabels': ['Quadratus Lumborum Block']}, {'name': 'Retrolaminar Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided retrolaminar block performed preoperatively using local anesthetic injection into the retrolaminar space for postoperative analgesia in lumbar disc herniation surgery', 'armGroupLabels': ['Retrolaminar Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'dilek icli, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'Nermin Kandemir', 'investigatorAffiliation': 'Kocaeli University'}}}}