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Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

NCT06120530 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-04-20

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse

Interventions

DRUG

Bupivacaine

Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.

OTHER

Saline

Placebo

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • James R Stewart · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-03-15
Completion
2024-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120530 on ClinicalTrials.gov