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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00695240
• Other study ID #: 06-310
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 9, 2008
• Last updated: June 10, 2008
• Start date: April 2007
• Est. completion date: July 2009

Study information

• Verified date: June 2008
• Source: St. Luke's Hospital, Kansas City, Missouri
• Contact: Tyler M Muffly, MD
• Phone: 816-404-1000
• Email: tylermuffly[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Pelvic Organ Prolapse
• Post-Operative Pain
• Prolapse

Intervention

Device:
• 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. One half percent bupivacaine was utilized.

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Kansas City, Missouri

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes