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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by St. Luke's Hospital, Kansas City, Missouri.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695240
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Luke's Hospital, Kansas City, Missouri
June 9, 2008
June 11, 2008
June 11, 2008
April 2007
July 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Secondary outcome was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups. [ Time Frame: Each day post-operatively ]
Same as current
Not Provided
Not Provided
 
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Post-Operative Pain
  • Pelvic Organ Prolapse
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.
Other Name: ON-Q PainBuster Post-Op Pain Relief System
Experimental: Bupiv analgesia
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.
Intervention: Device: Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00695240
06-310
No
Not Provided
Not Provided
Marilyn Horn, Institutional Review Board
St. Luke's Hospital, Kansas City, Missouri
Not Provided
Study Director: Tyler M Muffly, MD St. Luke's Hospital
St. Luke's Hospital, Kansas City, Missouri
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP