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

NCT ID: NCT02875015

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-05-31

Brief Summary

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.

Detailed 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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Liposomal Bupivacaine

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.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

20 mL 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

Suburethral Sling

Intervention Type: PROCEDURE

A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.

Bupivacaine Hydrochloride and Lidocaine

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride and Lidocaine

Intervention Type: DRUG

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.

Suburethral Sling

Intervention Type: PROCEDURE

A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.

Interventions

Liposomal Bupivacaine

20 mL 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

Intervention Type: DRUG

Bupivacaine Hydrochloride and Lidocaine

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.

Intervention Type: DRUG

Suburethral Sling

A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.

Intervention Type: PROCEDURE

Other Intervention Names

EXPAREL; Marcaine and Lidocaine; Midurethral Sling

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

charbel salamon

Fellowship Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charbel Salamon, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Morrristown Medical Center

Morristown, New Jersey, United States

Overlool Medical Center

Summit, New Jersey, United States

Countries

United States

Other Identifiers

883788-1

Identifier Type: -

Identifier Source: org_study_id