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Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

Primary Purpose

Pain, Postoperative, Major Abdominal Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP block
Epidural analgesia
EXPAREL
Bupivacaine
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • 18-85 years old
  • ASA Physical Status 1-3
  • Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries
  • Anticipated hospitalization of three nights
  • Expected requirement for parenteral opioids for at least 72 hours for postoperative pain
  • Able to use IV PCA systems.

Exclusion Criteria:

  • Hepatic disease, e.g. twice the normal levels of liver enzymes
  • Kidney disease, e.g. twice the normal level of serum creatinine
  • Bupivacaine sensitivity or known allergy
  • Women who are pregnant or breastfeeding
  • Anticoagulants considered to be a contraindication for epidural or TAP blocks.
  • Surgeries with high port sites will be excluded

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block with Exparel

Epidural analgesia with Bupivacaine

Arm Description

Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)

Epidural catheters with an infusion of Bupivacaine standard solution without additives

Outcomes

Primary Outcome Measures

VRS Pain score
Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies worst pain ever experienced. The VRS will be recorded every 30 minutes in the recovery area for the first 2 hours, then every 4 hours thereafter while awake for 72 hours.
Total opioid consumption
Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.

Secondary Outcome Measures

Activity after surgery
ViSi mobile (Sotera Wireless) patient monitoring system, a platform for comprehensive vital sign monitoring will be used to quantify patient activity over the initial 72 postoperative hours. This system continuously measures position (lying versus sitting) and activity.
Opioid related side effect
We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate opioid-related side effect. ORSDS questionnaires will be administered by a trained research fellow.
Blood pressure
Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours.
Quality of recovery after anesthesia
Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3.
Length of hospital stay
The length of hospital stay will be measured as days.
Total cost of care
The total cost of hospital stay will be collected at hospital discharge day or date of death from any cause, which comes first, assessed up to 100 weeks.

Full Information

First Posted
December 5, 2016
Last Updated
January 14, 2020
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02996227
Brief Title
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Official Title
Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
Detailed Description
The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Major Abdominal Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
532 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block with Exparel
Arm Type
Experimental
Arm Description
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
Arm Title
Epidural analgesia with Bupivacaine
Arm Type
Active Comparator
Arm Description
Epidural catheters with an infusion of Bupivacaine standard solution without additives
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
Intervention Type
Procedure
Intervention Name(s)
Epidural analgesia
Intervention Description
Epidural catheters will be inserted preoperatively.
Intervention Type
Drug
Intervention Name(s)
EXPAREL
Other Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.
Primary Outcome Measure Information:
Title
VRS Pain score
Description
Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies worst pain ever experienced. The VRS will be recorded every 30 minutes in the recovery area for the first 2 hours, then every 4 hours thereafter while awake for 72 hours.
Time Frame
Discharge from PACU until 72 hours after the end of surgery
Title
Total opioid consumption
Description
Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.
Time Frame
Discharge from PACU until 72 hours after the end of surgery
Secondary Outcome Measure Information:
Title
Activity after surgery
Description
ViSi mobile (Sotera Wireless) patient monitoring system, a platform for comprehensive vital sign monitoring will be used to quantify patient activity over the initial 72 postoperative hours. This system continuously measures position (lying versus sitting) and activity.
Time Frame
Discharge from PACU until 72 hours after the end of surgery
Title
Opioid related side effect
Description
We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate opioid-related side effect. ORSDS questionnaires will be administered by a trained research fellow.
Time Frame
The first, second and third postoperative mornings
Title
Blood pressure
Description
Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours.
Time Frame
Discharge from PACU until 72 hours after the end of surgery
Title
Quality of recovery after anesthesia
Description
Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3.
Time Frame
The first and third postoperative mornings
Title
Length of hospital stay
Description
The length of hospital stay will be measured as days.
Time Frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
Title
Total cost of care
Description
The total cost of hospital stay will be collected at hospital discharge day or date of death from any cause, which comes first, assessed up to 100 weeks.
Time Frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent 18-85 years old ASA Physical Status 1-3 Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries Anticipated hospitalization of three nights Expected requirement for parenteral opioids for at least 72 hours for postoperative pain Able to use IV PCA systems. Exclusion Criteria: Hepatic disease, e.g. twice the normal levels of liver enzymes Kidney disease, e.g. twice the normal level of serum creatinine Bupivacaine sensitivity or known allergy Women who are pregnant or breastfeeding Anticoagulants considered to be a contraindication for epidural or TAP blocks. Surgeries with high port sites will be excluded
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34969004
Citation
Turan A, Cohen B, Elsharkawy H, Maheshwari K, Soliman LM, Babazade R, Ayad S, Hassan M, Elkassabany N, Essber HA, Kessler H, Mao G, Esa WAS, Sessler DI; EXPLANE Study Group. Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. J Clin Anesth. 2022 May;77:110640. doi: 10.1016/j.jclinane.2021.110640. Epub 2021 Dec 27.
Results Reference
derived

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Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

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