Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

Indiana University

Status and phase: Completed; Phase 4

Conditions: Pelvic Organ Prolapse

Treatments: Other: Saline; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06120530

17120

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups, including a placebo group

Intraperitoneal bupivacaine

Active Comparator group

Description:

30 mL of bupivacaine without epinephrine 0.25%

Treatment:

Drug: Bupivacaine

placebo

Placebo Comparator group

Description:

Saline

Treatment:

Other: Saline