search
Back to results

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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine Hydrochloride and Lidocaine
Suburethral Sling
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Anesthetics, Anesthetic Effects, Mid-urethral sling

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Morrristown Medical Center
  • Overlool Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Bupivacaine

Bupivacaine Hydrochloride and Lidocaine

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Preoperative Quality of Recovery
Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
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.
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.

Full Information

First Posted
June 27, 2016
Last Updated
June 5, 2018
Sponsor
Atlantic Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT02875015
Brief Title
Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement
Official Title
Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Anesthetics, Anesthetic Effects, Mid-urethral sling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm 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.
Arm Title
Bupivacaine Hydrochloride and Lidocaine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
EXPAREL
Intervention Description
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
Intervention Name(s)
Bupivacaine Hydrochloride and Lidocaine
Other Intervention Name(s)
Marcaine and Lidocaine
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Suburethral Sling
Other Intervention Name(s)
Midurethral Sling
Intervention Description
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Primary Outcome Measure Information:
Title
Postoperative Day 1 Pain
Description
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.
Time Frame
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 Measure Information:
Title
Second Stage PACU Postoperative Pain
Description
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.
Time Frame
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.
Title
Postoperative Pain Upon Discharge
Description
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.
Time Frame
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.
Title
Postoperative Pain Four Hours After Discharge
Description
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.
Time Frame
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.
Title
Night of Surgery Postoperative Pain
Description
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.
Time Frame
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.
Title
Postoperative Days 2 through 7 Pain
Description
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.
Time Frame
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.
Title
Preoperative Quality of Recovery
Description
Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
Time Frame
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.
Title
Postoperative Days 1, 7 and 14 Quality of Recovery
Description
Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.
Time Frame
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.
Title
Postoperative Narcotic Consumption
Description
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.
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charbel Salamon, MD
Organizational Affiliation
Atlantic Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morrristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Overlool Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs