Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT05979493
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QL Block in Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007889', 'term': 'Leiomyoma'}], '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': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain as measured by Richmond Agitation Sedation Scale (RASS)', 'timeFrame': 'Up to 24 hours', 'description': 'RASS is measured from -5 to +4 with -5 being no response to voice or physical stimulation and +4 being overtly combative, violent, immediate danger to staff'}], 'primaryOutcomes': [{'measure': 'Time in minutes from first analgesic request as measured by medical chart review', 'timeFrame': 'Up to 24 hours'}, {'measure': 'Total number of doses of rescue analgesics given as measured by medical chart review', 'timeFrame': 'Up to 24 hours'}], 'secondaryOutcomes': [{'measure': 'Pain as measured by visual analog scale (VAS)', 'timeFrame': 'Up to 48 hours after discharge from hospital.', 'description': 'VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.'}, {'measure': 'Patient satisfaction with perioperative pain management measured on a scale of 1-10', 'timeFrame': 'Up to 48 hours after discharge from hospital.', 'description': 'Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QL Block', 'Myomectomy'], 'conditions': ['Postoperative Pain', 'Fibroid Uterus']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of uterine fibroids requiring surgical excision with preservation of the uterus\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Pre-existing diagnoses of anxiety or depression\n* Pre-existing coagulopathies\n* Pre-existing neuropathic or chronic pelvic pain\n* Chronic opioid use\n* Illiteracy due to inability to read and understand plain questionnaire\n* Non-English speaking\n* BMI \\>38'}, 'identificationModule': {'nctId': 'NCT05979493', 'briefTitle': 'QL Block in Laparoscopic Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'STUDY20230830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QL Block with Bupivacaine', 'description': 'Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'description': '30cc IM injection in each quadratus lumborum muscle (60cc total).', 'armGroupLabels': ['QL Block with Bupivacaine']}, {'name': 'Saline', 'type': 'DRUG', 'description': '30cc IM injection in each quadratus lumborum muscle (60cc total).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine P Haering, BA', 'role': 'CONTACT', 'email': 'cph43@case.edu', 'phone': '3392011531'}], 'facility': 'University Hospitals Ahuja Medical Center', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}], 'centralContacts': [{'name': 'Catherine P Haering, BA', 'role': 'CONTACT', 'email': 'cph43@case.edu', 'phone': '3392011531'}], 'overallOfficials': [{'name': 'Joseph Findley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph Findley MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'University Hospitals Department of Reproductive Endocrinology and Infertility', 'investigatorFullName': 'Joseph Findley MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}