Clinical trial NCT06120530: Intraperitoneal Bupivacaine for Pelvic Organ Prolapse
Official title: Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain Score at 4 Hours
timeFrame: 4 hours
Secondary outcomes:
measure: Pain Score at 8 Hours, 12 Hours and 24 Hours
timeFrame: 8 hours, 12 hours and 24 hours
measure: Total Opiate Consumption
timeFrame: First 24 hours postoperatively
measure: Time to First Narcotic
timeFrame: Up to 24 hours
measure: Hospital Length of Stay
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU north
state: Indiana
Study officials:
affiliation: Indiana University
name: James R Stewart
role: PRINCIPAL_INVESTIGATOR
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