Pelvic Organ Prolapse, Post-Operative Pain
Conditions
Keywords
Continuous bupivacaine infusion, Analgesia
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.
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.
Interventions
DEVICEContinuous 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.
Sponsors
St. Luke's Hospital, Kansas City, Missouri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactTyler M Muffly, MD
Backup ContactRichard Hill, MD
Outcome results
None listed