Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Urogynecologic Surgery

NCT ID: NCT02287246

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-11-30

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.

Detailed Description

Effective post-operative pain management is a crucial component of a patient's surgical course following Urogynecologic surgery. Narcotics are the cornerstone for post-operative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks5. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, this medication has not yet been reported within Urogynecology literature.

We propose a prospective, randomized, double blind, placebo controlled trial with 120 subjects recruited from the WRNMMC Urogynecology Clinic to study post-operative efficacy of Exparel® for pain control in patients undergoing Urogynecology surgery involving the posterior vaginal wall. Subjects will be randomized to receive either 20mL of extended-release bupivacaine or 20mL placebo.

The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.

Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extended-Release liposomal bupivacaine

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

Group Type: EXPERIMENTAL

Extended-Release liposomal bupivacaine (Exparel)

Intervention Type: DRUG

20mL

Placebo (normal saline)

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

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

20mL

Interventions

Extended-Release liposomal bupivacaine (Exparel)

20mL

Intervention Type: DRUG

Normal saline

20mL

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Christy Jones

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christin L Jones, DO

Role: PRINCIPAL_INVESTIGATOR

WRNMMC

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina L Jones, DO

Role: CONTACT

christina.l.jones50.mil@mail.mil

301-400-2468

Sandra L Hernandez, MD

Role: CONTACT

sandra.l.hernandez6@mail.mil

301-400-2468

Facility Contacts

Christina Jones, DO

Role: primary

christina.l.jones50.mil@mail.mil

301-400-2468

Other Identifiers

399635

Identifier Type: -

Identifier Source: org_study_id