Phase 4
N=91
Intraperitoneal Bupivacaine for Pelvic Organ Prolapse
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT06120530 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Pain Score at 4 Hours — 3.16; 3.77 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score at 4 Hours |
3.16; 3.77 | — |
| SECONDARY Pain Score at 8 Hours, 12 Hours and 24 Hours |
3.27; 3.30; 2.84; 2.96; 3.00; 2.37 | — |
| SECONDARY Total Opiate Consumption |
25.4; 22.0 | — |
| SECONDARY Time to First Narcotic |
98.0; 96.0 | — |
| SECONDARY Hospital Length of Stay |
1.0; 1.0 | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06120530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.