Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: Female

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 perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine

Criteria

Inclusion Criteria:

• English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse

Exclusion Criteria:

• 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