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

Phase 2

• Conditions: Post-Operative Pain; Pelvic Organ Prolapse
• Interventions: Device: Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)

• Registration Number: NCT00695240
• Lead Sponsor: St. Luke's Hospital, Kansas City, Missouri

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-04
• Status Verified: 2008-06
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Last Update Submitted: 2008-06-10
• Study First Posted: 2008-06-11
• Last Update Posted: 2008-06-11
• Primary Completion: 2009-07
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupiv analgesia	Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

St. Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States