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Extended-Release liposomal bupivacaine for Postoperative Pain

Phase 4
Waitlist Available
Led By Christin L Jones, DO
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females \>18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis (including but not limited to posterior colporrhaphy, colpocleisis, sphincter repair, sphincteroplasty, perineoplasty) at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post operative day 1 and 3
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.

Eligible Conditions
  • Postoperative Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative day 1 and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and post operative day 1 and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative post-operative pain control
Secondary study objectives
Evaluate vaginal pain on Post-operative day 7

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Extended-Release liposomal bupivacaineExperimental Treatment1 Intervention
20mL Extended-release liposomal bupivacaine injected into the posterior vaginal wall following surgery
Group II: Placebo (normal saline)Active Control1 Intervention
20mL normal saline injected into the posterior vaginal wall following surgery

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
140 Previous Clinical Trials
33,053 Total Patients Enrolled
1 Trials studying Postoperative Pain
120 Patients Enrolled for Postoperative Pain
Christin L Jones, DOPrincipal InvestigatorWRNMMC
~11 spots leftby Nov 2025
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