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

NCT02875015 | Completed DMC

• 1 other identifier: 883788-1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Keywords

Anesthetics; Anesthetic Effects; Mid-urethral sling

Outcome Measures

Primary Outcomes (1)

• Postoperative Day 1 Pain

  Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed.

  Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

Secondary Outcomes (8)

• Second Stage PACU Postoperative Pain

  The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.

• Postoperative Pain Upon Discharge

  The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.

• Postoperative Pain Four Hours After Discharge

  Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

• Night of Surgery Postoperative Pain

  Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

• Postoperative Days 2 through 7 Pain

  Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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.

Drug: Liposomal Bupivacaine; Procedure: Suburethral Sling

Bupivacaine Hydrochloride and Lidocaine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hydrochloride and Lidocaine; Procedure: Suburethral Sling

Interventions

Liposomal Bupivacaine 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

Also known as: EXPAREL

Liposomal Bupivacaine

Bupivacaine Hydrochloride and Lidocaine 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.

Also known as: Marcaine and Lidocaine

Bupivacaine Hydrochloride and Lidocaine

Suburethral Sling PROCEDURE

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

Also known as: Midurethral Sling

Bupivacaine Hydrochloride and Lidocaine; Liposomal Bupivacaine

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (2)

Morrristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Overlool Medical Center

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Lidocaine; Suburethral Slings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Prostheses and Implants; Equipment and Supplies

Study Officials

• Charbel Salamon, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship Director

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: August 23, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)