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

NCT00695240 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-06-11

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Tyler M Muffly, MD · St. Luke's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695240 on ClinicalTrials.gov