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Clinical Trials/NCT00695240
NCT00695240
Unknown
Phase 2

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

St. Luke's Hospital, Kansas City, Missouri1 site in 1 country80 target enrollmentApril 2007

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post-Operative Pain
Sponsor
St. Luke's Hospital, Kansas City, Missouri
Enrollment
80
Locations
1
Primary Endpoint
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.
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
July 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: Each day post-operatively

Secondary Outcomes

  • 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)

Study Sites (1)

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