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

NCT00695240 | Unknown Phase 2

• 1 other identifier: 06-310
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Continuous bupivacaine infusion; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Each day post-operatively

Secondary Outcomes (1)

• 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 Arms (1)

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)

Interventions

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

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.

Also known as: ON-Q PainBuster Post-Op Pain Relief System

Bupiv analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients greater than 18 years of age
• Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO.

You may not qualify if:

• Patients with chronic pain conditions requiring daily narcotics were excluded

Sponsors & Collaborators

• St. Luke's Hospital, Kansas City, Missouri: lead

Study Sites (1)

St. Luke's Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pelvic Organ Prolapse; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Tyler M Muffly, MD

  St. Luke's Hospital

  STUDY DIRECTOR

Central Study Contacts

Tyler M Muffly, MD

CONTACT

816-404-1000; tylermuffly@hotmail.com

Richard Hill, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: April 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 11, 2008

Record last verified: 2008-06

Locations

US (1)