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Local Anesthetic

Bupiv analgesia for Pelvic Organ Prolapse

Phase 2 & 3
Waitlist Available
Research Sponsored by St. Luke's Hospital, Kansas City, Missouri
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each day post-operatively
Awards & highlights

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.

Eligible Conditions
  • Pelvic Organ Prolapse
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each day post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and each day post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The 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.
Secondary outcome measures
was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bupiv analgesiaExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

St. Luke's Hospital, Kansas City, MissouriLead Sponsor
3 Previous Clinical Trials
1,756 Total Patients Enrolled
Tyler M Muffly, MDStudy DirectorSt. Luke's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
2007. "Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00695240.
All > Exparel
~4 spots leftby May 2025
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