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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875015
• Other study ID #: 883788-1
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Morrristown Medical Center	Morristown	New Jersey
United States	Overlool Medical Center	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.