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

Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Liposomal Bupivacaine; Procedure: Suburethral Sling; Drug: Bupivacaine Hydrochloride and Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morrristown Medical Center
    • Summit, New Jersey, United States, 07901
      • Overlool Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: EXPAREL; Procedure: Suburethral Sling; A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.; Other Names: Midurethral Sling
Active Comparator: 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.	Procedure: Suburethral Sling; A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.; Other Names: Midurethral Sling; 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.; Other Names: Marcaine and Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Second Stage PACU Postoperative Pain	Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU.	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	Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital.	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	Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced. This will be recorded 4 hours after being discharged from the hospital.	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	Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery.	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	Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7.	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.
Preoperative Quality of Recovery	Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.	The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
Postoperative Days 1, 7 and 14 Quality of Recovery	Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.	The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Postoperative Narcotic Consumption	The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed.	The patient will record narcotic consumption each day from the day of surgery to postop day 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.

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Investigators: Principal Investigator: Charbel Salamon, MD, Atlantic Health System

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Anesthetics; Mid-urethral sling; Anesthetic Effects
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: 883788-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO