Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: Bupivacaine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at 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 | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at 8, 12, 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 | Up to 24 hours | 
| Total opiate consumption | total opiate consumption postoperatively while inpatient as determined by morphine milligram equivalents (MME) | First 24 hours postoperatively | 
| Time to first narcotic | time to first narcotic dose during inpatient stay | Up to 24 hours | 
| Hospital length of stay | hospital length of stay | Up to 24 hours |