Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

April 3, 2025 updated by: James Ryan Stewart, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • IU north

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Saline
Other: Saline
Placebo
Active Comparator: Intraperitoneal bupivacaine
30 mL of bupivacaine without epinephrine 0.25%
Drug: Bupivacaine
Intraperitoneal Bupivicaine without epinephrine 30 mg administered following completion of pelvic organ prolapse repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score at 4 Hours
Time Frame: 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
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score at 8 Hours, 12 Hours and 24 Hours
Time Frame: 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
8 hours, 12 hours and 24 hours
Total Opiate Consumption
Time Frame: First 24 hours postoperatively
Total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)
First 24 hours postoperatively
Time to First Narcotic
Time Frame: Up to 24 hours
Time to first narcotic dose during inpatient stay
Up to 24 hours
Hospital Length of Stay
Time Frame: Up to 24 hours
Hospital length of stay
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: James R Stewart, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

July 29, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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