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

St. Luke's Hospital, Kansas City, Missouri

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pelvic Organ Prolapse; Post-Operative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00695240

06-310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Bupiv analgesia

Experimental group

Description:

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.

Treatment:

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