Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling

TriHealth

Status and phase

Terminated

Phase 4

Conditions

Pain

Treatments

Drug: Liposomal bupivacaine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02591888

14-081

Details and patient eligibility

About

Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.

Full description

The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.

Enrollment

18 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults > 18 years of age
Planning for outpatient surgical treatment of SUI with placement of a transobturator 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
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
Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.