Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT04428320
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS analog scale on post-op day #1', 'timeFrame': 'postop day #1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Floor Prolapse', 'Surgery', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control', 'detailedDescription': 'Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:\n\n1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:\n\n \\- 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).\n2. Control- No additional treatment (standard of care).\n\nThe patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pelvic organ prolapse surgery for female genitalia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Able to read English and give informed consent\n* Undergoing VAGINAL pelvic reconstructive surgery for POP\n\nExclusion Criteria:\n\n* Hypersensitivity or allergy to amide anesthetics\n* Documented chronic pain condition\n\n o (back pain, pelvic pain, fibromyalgia, etc.)\n* Bleeding disorder\n* Connective tissue disorder\n* Neuromuscular disorder\n* Cardiac conduction abnormality or channelopathy\n* Hepatic Impairment\n* Renal Impairment\n* History of, or current, narcotic or alcohol dependence\n* History of pelvic radiation or gynecologic malignancy'}, 'identificationModule': {'nctId': 'NCT04428320', 'briefTitle': 'The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cooper Health System'}, 'officialTitle': 'The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery', 'orgStudyIdInfo': {'id': '19-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivicaine pelvic floor muscle injection', 'description': 'Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery', 'interventionNames': ['Procedure: Pelvic floor injection']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care (no injection) preoperatively', 'description': 'No injection - standard analgesia'}], 'interventions': [{'name': 'Pelvic floor injection', 'type': 'PROCEDURE', 'description': 'Injection of 10 cc of bupivacaine', 'armGroupLabels': ['Bupivicaine pelvic floor muscle injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08105', 'city': 'Camden', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lioudmila Lipetskaia', 'role': 'CONTACT', 'email': 'lipetskaia-lioudmila@cooperhealth.edu', 'phone': '610-462-1608'}], 'facility': 'Cooper Health University', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}], 'centralContacts': [{'name': 'Lioudmila Lipetskaia, MD', 'role': 'CONTACT', 'email': 'lipetskaia-lioudmila@cooperhealth.edu', 'phone': '610-462-608'}, {'name': 'Devon Smith, MD', 'role': 'CONTACT', 'email': 'smith-devon@cooperhealth.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing planned as of now'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cooper Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}