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

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Major Abdominal Surgery
• Intervention / Treatment: Procedure: TAP block; Drug: EXPAREL; Procedure: Epidural analgesia; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block with Exparel; Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)	Procedure: TAP block; Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.; Drug: EXPAREL; 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.; Other Names: Liposomal Bupivacaine
Active Comparator: Epidural analgesia with Bupivacaine; Epidural catheters with an infusion of Bupivacaine standard solution without additives	Procedure: Epidural analgesia; Epidural catheters will be inserted preoperatively.; Drug: Bupivacaine; 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.; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours	The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
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.	During the 72 hours after discharge from the PACU.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Duration of Activity	defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.	During the initial 72 postoperative hours.
Opioid-related Side Effect	We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.	The first, second and third postoperative mornings
Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.	Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP <65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours.	Data was recorded at 15-s intervals during the initial 72 postoperative hours.
Quality of Recovery After Anesthesia	Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = "none of the time [poor]" to 10 = "all of the time [excellent]"; Conversely, for negative items, 10 = "none of the time [excellent]" to 0 = "all of the time [poor]". Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).	The first and third postoperative mornings
Length of Hospital Stay	The length of hospital stay will be measured as days.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hypoxemia	ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%.	Data was recorded at 15-s intervals during the initial 72 postoperative hours.
Persistent Postoperative Incisional Pain- MBPI Pain Intensity	Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).	At the 90-day follow up
Persistent Postoperative Incisional Pain- MBPI Pain Interference	Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).	At the 90-day follow up

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Alparslan Turan, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimated): December 19, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 16-1449 -EXPLANE Block