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NCT Number: NCT06120530

Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IU north

Carmel, Indiana, 46032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Saline

Other

Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Total Opiate Consumption

    Time frame: First 24 hours postoperatively

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

  3. Time to First Narcotic

    Time frame: Up to 24 hours

    Time to first narcotic dose during inpatient stay

  4. Hospital Length of Stay

    Time frame: Up to 24 hours

    Hospital length of stay

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Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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