Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair

17120

The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair. The investigators hypothesize that use of intraperitoneal Bupivacaine will decrease postoperative pain scores and opiate consumption in the postoperative period, following pelvic organ prolapse repair.

2023-08-15

2025-01-01

2025-01-01

Recruiting

Early phase I

90

4.1 Inclusion Criteria List the criteria: * Age \>= 18 years * Access to cell phone with text messaging capabilities (for same day surgery discharge) * Patients undergoing pelvic organ prolapse repair with peritoneal access 4.2 Exclusion Criteria List the criteria: * Bupivacaine allergy * History of epilepsy or other seizure disorder * EKG demonstrating asymptomatic sinus bradycardia \<40 bpm, symptomatic sinus bradycardia \<60 bpm, first degree AV block, second degree AV block, third degree AV block, prolonged QT, atrial fibrillation, supraventricular tachycardia, or myocardial infarction * Chronic liver disease proved by any ALT or AST elevation greater than 2x upper limit of normal * Serum bilirubin elevation in excess of 5 mg/dL * G6PD deficiency * Weight less than 100 lbs * Chronic opiate use

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-11-07