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Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06120530
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
16.6
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair
Actual Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.
Placebo Comparator: placebo

Saline

Other: Saline
Placebo

Outcome Measures

Primary Outcome Measures

  1. Pain score at 4 hours [Up to 24 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

  1. Pain score at 8, 12, 24 hours [Up to 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

  2. Total opiate consumption [First 24 hours postoperatively]

    total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME)

  3. Time to first narcotic [Up to 24 hours]

    time to first narcotic dose during inpatient stay

  4. Hospital length of stay [Up to 24 hours]

    hospital length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IU north Carmel Indiana United States 46032

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: James R Stewart, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
James Ryan Stewart, Assistant Professor of Clinical Obstetrics & Gynecology, Indiana University
ClinicalTrials.gov Identifier:
NCT06120530
Other Study ID Numbers:
  • 17120
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Bupivacaine

Study Results

No Results Posted as of Nov 7, 2023