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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT02449915

Run by

TriHealth Inc.

People needed

70

Starts

2015-03-01

Expected to finish

2016-08-01

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Urogynecology Associates — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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