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

NCT02287246 | Unknown Phase 4

• 1 other identifier: 399635
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cumulative post-operative pain control

  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.

  Post operative day 1 and 3

Secondary Outcomes (1)

• Evaluate vaginal pain on Post-operative day 7

  Post-operative day 7

Study Arms (2)

Extended-Release liposomal bupivacaine

EXPERIMENTAL

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

Drug: Extended-Release liposomal bupivacaine (Exparel)

Placebo (normal saline)

ACTIVE COMPARATOR

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

Drug: Normal saline

Interventions

Extended-Release liposomal bupivacaine (Exparel) DRUG

20mL

Also known as: Exparel

Extended-Release liposomal bupivacaine

Normal saline DRUG

20mL

Placebo (normal saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christin L Jones, DO

  WRNMMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina L Jones, DO

CONTACT

301-400-2468; christina.l.jones50.mil@mail.mil

Sandra L Hernandez, MD

CONTACT

301-400-2468; sandra.l.hernandez6@mail.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)