Recruiting
Phase 2
Phase 3

Bupivacaine

Sponsor:

St. Luke's Hospital, Kansas City, Missouri

Code:

NCT00695240

Conditions

Post-Operative Pain

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)

Study Details

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.

Conditions

Post-Operative Pain

Pelvic Organ Prolapse

Study ID

NCT00695240

Start date

Apr, 2007

Status verified date

Jun, 2008

Completion date

Jul, 2009

Anticipated

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Tyler M Muffly, MD

816-404-1000tylermuffly@hotmail.com

Richard Hill, MD

816-932-1758rihill@saint-lukes.org

Locations

St. Luke's Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Tyler Muffly, MD

816-404-1000tylermuffly@hotmail.com

More Information

Sponsor

St. Luke's Hospital, Kansas City, Missouri

Last update posted

Jun 11, 2008

Last verified

Jun, 2008

Keywords

  • Continuous bupivacaine infusion
  • Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Luke's Hospital, Kansas City, Missouri on 2008-06-11.