Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

Phase 4

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Saline; Drug: Bupivacaine

• Registration Number: NCT06120530
• Lead Sponsor: Indiana University

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-29
• Study Start: 2023-08-16
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-07
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Results First Submitted: 2025-03-10
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Results First Posted: 2025-04-20
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Saline	Saline
Intraperitoneal bupivacaine	Bupivacaine	30 mL of bupivacaine without epinephrine 0.25%

Primary Outcome Measures

Name	Time	Method
Pain Score at 4 Hours	4 hours	Patient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair

Secondary Outcome Measures

Name	Time	Method
Total Opiate Consumption	First 24 hours postoperatively	Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)
Hospital Length of Stay	Up to 24 hours	Hospital length of stay
Pain Score at 8 Hours, 12 Hours and 24 Hours	8 hours, 12 hours and 24 hours	Pain scores as determined by numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at approximately 8, 12 and 24 hours
Time to First Narcotic	Up to 24 hours	Time to first narcotic dose during inpatient stay

Trial Locations

Locations (1)

IU north; 🇺🇸 Carmel, Indiana, United States