Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05702827
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2023-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D056650', 'term': 'Vulvodynia'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723006', 'term': 'bupivacaine-meloxicam drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery', 'timeFrame': '72 hours post surgery', 'description': 'Pain medication diary'}], 'secondaryOutcomes': [{'measure': 'Compare average pain on each day post operatively', 'timeFrame': '72 hours post surgery', 'description': '11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3'}, {'measure': 'Compare worst pain on each day post operatively', 'timeFrame': '72 hours post surgery', 'description': '11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3'}, {'measure': 'Compare satisfaction with pain control post operatively', 'timeFrame': '72 hours post surgery', 'description': '11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence', 'Surgical Incision', 'Pain Vulva']}, 'descriptionModule': {'briefSummary': 'This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)\n* English as first language\n\nExclusion Criteria:\n\n* patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy\n* NSAID use within 7 days of surgery\n* steroid use within 10 days\n* daily opioid use in the last 3 months\n* long acting opioids within 3 days\n* any opioids within 24h\n* patients unable to consent for themselves\n* patients allergic to meloxicam or bupivacaine\n* pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT05702827', 'briefTitle': 'Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery', 'orgStudyIdInfo': {'id': '22-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupivacaine-meloxicam', 'description': 'All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group', 'interventionNames': ['Drug: Bupivacaine-Meloxicam']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure.'}], 'interventions': [{'name': 'Bupivacaine-Meloxicam', 'type': 'DRUG', 'description': 'All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.', 'armGroupLabels': ['bupivacaine-meloxicam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Urogynecology Associates', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Trihealth (Good Samaritan Hospital, Bethesda North Hospital)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}