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

NCT ID: NCT00695240

Last Updated: 2008-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Operative Pain Pelvic Organ Prolapse

Keywords

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Continuous bupivacaine infusion Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ON-Q PainBuster Post-Op Pain Relief System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Hospital, Kansas City, Missouri

OTHER

Sponsor Role lead

Responsible Party

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Institutional Review Board

Principal Investigators

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Tyler M Muffly, MD

Role: STUDY_DIRECTOR

St. Luke's Hospital

Locations

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St. Luke's Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tyler M Muffly, MD

Role: CONTACT

Phone: 816-404-1000

Email: [email protected]

Richard Hill, MD

Role: CONTACT

Phone: 816-932-1758

Email: [email protected]

Facility Contacts

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Tyler Muffly, MD

Role: primary

Other Identifiers

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06-310

Identifier Type: -

Identifier Source: org_study_id