Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-06 @ 11:49 AM
Study NCT ID:
NCT03067168
Status:
UNKNOWN
Last Update Posted:
2019-01-07
First Post:
2017-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects will not know if they received an injection of bupivacaine or placebo, i.e., normal saline after completion of surgery. The surgeon, as well as any investigator or study personnel, will be blinded to injection type.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-24', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with improvement in pain, scored on a 10 point numerical pain scale.', 'timeFrame': '1 year', 'description': 'Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Postoperative care satisfaction scores, graded with a post-operative survey.', 'timeFrame': '1 year', 'description': 'Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo.'}, {'measure': 'Measure of morphine equivalents used in patients postoperatively.', 'timeFrame': '1 year', 'description': 'A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts.'}, {'measure': 'Length of hospital stay measured in hours.', 'timeFrame': '1 year', 'description': 'Length, in hours, of hospital stay between study cohorts.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '34171880', 'type': 'DERIVED', 'citation': 'Kaeser CT, Rothenberger R, Zoorob D, Whiteside JL. Bupivacaine Use After Posterior Colporrhaphy to Reduce Postoperative Pain: A Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):72-76. doi: 10.1097/SPV.0000000000001082.'}]}, 'descriptionModule': {'briefSummary': 'To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients that are eligible would be undergoing vaginal prolapse surgery including posterior colporrhaphy, therefore would need to have a vagina to be enrolled in this study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.\n\nExclusion Criteria:\n\n* Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.'}, 'identificationModule': {'nctId': 'NCT03067168', 'briefTitle': 'A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.', 'organization': {'class': 'OTHER', 'fullName': 'The Christ Hospital'}, 'officialTitle': 'A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.', 'orgStudyIdInfo': {'id': 'TCH# 15-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine Arm', 'description': 'The subjects of this arm will receive an injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalad of the first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'The subjects of this arm will receive an injection of 5mL of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalic from first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.', 'interventionNames': ['Drug: normal saline 0.9%']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.', 'armGroupLabels': ['Bupivacaine Arm']}, {'name': 'normal saline 0.9%', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': '5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'The University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Carson T Kaeser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Christ Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christ Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kansas Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow in Female Pelvic Medicine and Reconstructive Surgery', 'investigatorFullName': 'Carson T. Kaeser, MD', 'investigatorAffiliation': 'The Christ Hospital'}}}}