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

Sponsored by:	St. Luke's Hospital, Kansas City, Missouri
Information provided by:	St. Luke's Hospital, Kansas City, Missouri
ClinicalTrials.gov Identifier:	NCT00695240

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 II Phase III

MedlinePlus related topics: Pelvic Support Problems

Drug Information available for: Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair

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
Bupiv analgesia: Experimental 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.

Arms

Assigned Interventions

Bupiv analgesia: Experimental

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.

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

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

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

Keywords provided by St. Luke's Hospital, Kansas City, Missouri:

Continuous bupivacaine infusion
Analgesia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Signs and Symptoms
Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases
Bupivacaine

Pain
Intestinal Diseases
Rectal Diseases
Prolapse
Pain, Postoperative
Rectal Prolapse

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009