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