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Exparel pudendal block for Vaginal Prolapse

Phase 4
Waitlist Available
Research Sponsored by Atlantic Health System
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 up to 24 hours before surgery and 72 hours post operative
Awards & highlights

Summary

A pudendal nerve block is a procedure where a local anesthetic is injected where the pudendal nerve is located. This allows quick pain relief to the perineum, vulva, and vagina. The purpose of this research study is see if injecting a long-acting local anesthetic, called Liposomal Bupivacaine (EXPAREL), will result in less post-operative pain after having vaginal prolapse surgery. Typical post-operative pain lasts a few days. Short-acting anesthetics only provide pain relief in the few hours after surgery. EXPAREL will add the benefit of longer acting pain relief that can last up to 72 hours with the same safety profile. EXPAREL is an FDA-approved medication. It has been used and studied extensively in gynecologic surgery for incisional pain. It has also been studied in Urology and Orthopedic surgery with an excellent safety profile with good pain relief.

Eligible Conditions
  • Vaginal Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily post-op days 1-3 and 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily post-op days 1-3 and 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain on postoperative day one
Secondary study objectives
Ambulatory Quality of Life questionnaire (QoR)
Average pain each day
Most intense pain each day
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel pudendal blockExperimental Treatment1 Intervention
This group will have intra-operative pudendal block performed with Liposomal Bupivacaine (EXPAREL) solution.
Group II: Comparison groupActive Control1 Intervention
This group will be those to receive current standard treatment with no pudendal block performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Atlantic Health SystemLead Sponsor
54 Previous Clinical Trials
7,449 Total Patients Enrolled
~13 spots leftby Sep 2025