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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tyler M Muffly, MD | Contact | 816-404-1000 | tylermuffly@hotmail.com | |
| Richard Hill, MD | Contact | 816-932-1758 | rihill@saint-lukes.org |
| Name | Affiliation | Role |
|---|---|---|
| Tyler M Muffly, MD | St. Luke's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
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|
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D056887 | Pelvic Organ Prolapse |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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