Expired Study
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Cincinnati, Ohio 45220


Purpose:

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.


Study summary:

In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences. This study seeks 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. The secondary aim of the study is to determine which port site, if any, is the most painful after robotic sacrocolpopexy.


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


NCT ID:

NCT02449915


Primary Contact:

Principal Investigator
Rachel Pauls, MD
Cincinnati Urogynocolgy Associates


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45220
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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