Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

Study Overview
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Brief Summary
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This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.

Detailed Description
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Direct post-operative analgesia can be administered via a direct continuous analgesia pumps providing local anesthetic into a dissected area. To date, no studies have been conducted to evaluate pain control or infection with vaginal placement of catheters for pelvic organ prolapse surgery. To help pelvic surgeons assess the relative benefit of continuous local infusion of topical anesthetic following sacrospinous ligament fixation versus PCA pump, we compared pain scores, narcotic, anti-pruritic and anti-emetic drug usage, and wound complications.

Official Title
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Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

Conditions
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Post-Operative Pain, Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients greater than 18 years of age Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO. Exclusion Criteria: Patients with chronic pain conditions requiring daily narcotics were excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupiv analgesia<br>Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. The catheter was placed in the operating room with a peel-away trocar and attached to the pump. The trocar was inserted through a 5 mm stab incision made near the superior part of the pubic bone between the genitoinguinal fold and the midline of the symphysis. Once through the incision, the trocar is advanced subcutaneously and made to exit the posterior fourchette just beneath the posterior vaginal mucosa where it is advanced by tenting up the skin. | Device: Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)<br>* Patients assigned to the study group had an ON-Q PainBuster Post-Op Pain Relief System (270 ml x 4 ml/hr, dual catheter, 2 ml per site, 72 hours continuous) with dual five inch fenestrated catheters placed at the sacrospinous ligament. One half percent bupivacaine was utilized.<br>* Other names: ON-Q PainBuster Post-Op Pain Relief System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was a difference in the Wisconsin Brief Pain Inventory and Visual Acuity Score after treatment with the direct continuous analgesia device compared to PCA alone. |  | Each day post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups. |  | Each day post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous bupivacaine infusion, Analgesia