Status:
COMPLETED
Intraperitoneal Bupivacaine for Pelvic Organ Prolapse
Lead Sponsor:
Indiana University
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-90 years
Phase:
PHASE4
Brief Summary
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. T...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06120530
Start Date
August 16 2023
End Date
March 15 2024
Last Update
April 20 2025
Active Locations (1)
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1
IU north
Carmel, Indiana, United States, 46032