Status:
COMPLETED
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorr...
Detailed Description
Liposomal bupivacaine (EXPAREL; Pacira Pharmaceuticals, San Diego, CA) is an extended release local anesthetic approved by the Food and Drug Administration since 2011 for the treatment of postsurgical...
Eligibility Criteria
Inclusion
- English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse
Exclusion
- Planned regional anesthesia
- Allergy or contraindication to bupivacaine
- Allergy or contraindication to opioids
- Allergy or contraindication to non-steroidal medications
- Planned laparotomy
- Chronic pain diagnosis and/or chronic narcotic use
Key Trial Info
Start Date :
July 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03875664
Start Date
July 23 2018
End Date
March 31 2019
Last Update
September 13 2022
Active Locations (1)
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1
Women's Center for Pelvic Health
Charlotte, North Carolina, United States, 28207