Recruiting

Extended-Release Liposomal Bupivacaine

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT02287246

Conditions

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Extended-Release liposomal bupivacaine (Exparel)

Normal saline

Study Details

Brief 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.

Conditions

Postoperative Pain

Study ID

NCT02287246

Start date

Oct, 2014

Status verified date

May, 2016

Completion date

Nov, 2016

Anticipated

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

Known allergy to amide local anesthetics Unstable cardiac arrhythmia Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer) Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable) Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery Significant history of opioid or alcohol abuse or addiction (requiring treatment) Concurrent pain management requiring the use of epidural anesthesia

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Extended-Release liposomal bupivacaine

20mL Extended-release liposomal bupivacaine injected into the posterior vaginal wall following surgery

active comparator: Placebo (normal saline)

20mL normal saline injected into the posterior vaginal wall following surgery

Interventions

Extended-Release liposomal bupivacaine (Exparel)

20mL

Normal saline

20mL

Primary outcome measure

  • Cumulative post-operative pain control [ Time Frame: Post operative day 1 and 3 ]

Central Contacts and Locations

Central contacts

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

May 24, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2016-05-24.