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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by St. Luke's Hospital, Kansas City, Missouri.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Luke's Hospital, Kansas City, Missouri
ClinicalTrials.gov Identifier:
NCT00695240
First received: June 9, 2008
Last updated: June 10, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Post-Operative Pain
Pelvic Organ Prolapse
Device: Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Kansas City, Missouri:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695240

Contacts
Contact: Tyler M Muffly, MD 816-404-1000 tylermuffly@hotmail.com
Contact: Richard Hill, MD 816-932-1758 rihill@saint-lukes.org

Locations
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Tyler Muffly, MD    816-404-1000    tylermuffly@hotmail.com   
Sub-Investigator: Tyler Muffly, MD         
Sponsors and Collaborators
St. Luke's Hospital, Kansas City, Missouri
Investigators
Study Director: Tyler M Muffly, MD St Luke's Hospital
  More Information

No publications provided

Responsible Party: Marilyn Horn, Institutional Review Board
ClinicalTrials.gov Identifier: NCT00695240     History of Changes
Other Study ID Numbers: 06-310
Study First Received: June 9, 2008
Last Updated: June 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's Hospital, Kansas City, Missouri:
Continuous bupivacaine infusion
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Prolapse
Pelvic Organ Prolapse
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pathological Conditions, Anatomical
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014