Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement

Atlantic Health System

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine Hydrochloride and Lidocaine; Drug: Liposomal Bupivacaine; Procedure: Suburethral Sling

Study type: Interventional

Funder types: Other

Identifiers

NCT02875015

883788-1

Details and patient eligibility

About

Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.

Full description

This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.

Enrollment: 57 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA physical status I-III
• Age >18 years
• Not Pregnant
• Able to give informed consent
• Electively chose surgical management of SUI with a suburethral sling

Exclusion criteria

• Pregnant or nursing
• Allergy to amide anesthetics
• History of drug or 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
• Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
• Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
• Administration of an investigational drug within 30 days before this study
• Chronic pain syndromes
• Daily NSAID or opioid use
• Patients undergoing concomitant procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.

Treatment:

Procedure: Suburethral Sling

Drug: Liposomal Bupivacaine

Bupivacaine Hydrochloride and Lidocaine

Active Comparator group

Description:

Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.

Treatment:

Procedure: Suburethral Sling

Drug: Bupivacaine Hydrochloride and Lidocaine