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Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Incontinence, Stress

Intervention: liposomal bupivacaine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: TriHealth Inc.

Overall contact:
Michaela Eschenbacher, MPH, Phone: 513-862-2341, Email: michaela_eschenbacher@trihealth.com


The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.

Clinical Details

Official title: The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Pain on postoperative day one

Secondary outcome:

Pain upon discharge from post-anesthesia care unit (PACU)

Pain upon discharge from same day surgery

Pain at four hours after discharge home

Total narcotic consumption

Satisfaction with pain control at 1 week postoperative visit


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Adults greater than 18 years of age

- Planning for outpatient surgical treatment of stress urinary incontinence with

placement of a retropubic suburethral sling under general anesthesia Exclusion Criteria:

- Pregnant or nursing

- Allergy to bupivacaine

- History of drug/alcohol abuse

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

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

- Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory

drugs (NSAID)

- Administration of an investigational drug within 30 days before study

- Chronic pain syndromes

- Daily NSAID/opioid use

- Patients having concomitant procedures or not undergoing general anesthesia

Locations and Contacts

Michaela Eschenbacher, MPH, Phone: 513-862-2341, Email: michaela_eschenbacher@trihealth.com

Cincinnati Urogynecology Associates, Cincinnati, Ohio 45220, United States; Recruiting
Vivian Ghodsi, RN, Phone: 513-853-4213, Email: vivian_ghodsi@trihealth.com
Additional Information

Starting date: November 2014
Last updated: February 23, 2015

Page last updated: August 23, 2015

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