Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

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.

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