Status:
UNKNOWN
Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Urogynecologic Surgery
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 controlle...
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 frequ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02287246
Start Date
October 1 2014
End Date
November 1 2016
Last Update
May 24 2016
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889