Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Adults 18 years of age or older

• Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia

• Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

Exclusion Criteria:

• Pregnant or nursing

• Allergy to bupivacaine

• History of drug/alcohol abuse

• Severe cardiovascular, hepatic, renal disease, or neurological impairment

• Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery

• Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs (NSAID)

• Administration of an investigational drug within 30 days before study

• Chronic pain syndromes

• Daily NSAID/opioid use

• Patients not undergoing general anesthesia

• Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair