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

NCT02996227 | Completed Results DMC

• 1 other identifier: 16-1449 -EXPLANE Block
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain, Postoperative; Major Abdominal Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Cumulative Duration of Activity

  During the initial 72 postoperative hours.

• Opioid-related Side Effect

  The first, second and third postoperative mornings

• Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.

  Data was recorded at 15-s intervals during the initial 72 postoperative hours.

• Quality of Recovery After Anesthesia

  The first and third postoperative mornings

• Length of Hospital Stay

  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 Outcomes (3)

• Duration of Hypoxemia

  Data was recorded at 15-s intervals during the initial 72 postoperative hours.

• Persistent Postoperative Incisional Pain- MBPI Pain Intensity

  At the 90-day follow up

• Persistent Postoperative Incisional Pain- MBPI Pain Interference

  At the 90-day follow up

Study Arms (2)

TAP block with Exparel

EXPERIMENTAL

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

Procedure: TAP block; Drug: EXPAREL

Epidural analgesia with Bupivacaine

ACTIVE COMPARATOR

Epidural catheters with an infusion of Bupivacaine standard solution without additives

Procedure: Epidural analgesia; Drug: Bupivacaine

Interventions

TAP block PROCEDURE

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

TAP block with Exparel

Epidural analgesia PROCEDURE

Epidural catheters will be inserted preoperatively.

Epidural analgesia with Bupivacaine

EXPAREL DRUG

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.

Also known as: Liposomal Bupivacaine

TAP block with Exparel

Bupivacaine DRUG

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.

Also known as: Marcaine

Epidural analgesia with Bupivacaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 34969004 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Epidural; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Fabio Rodriguez
• Organization: Cleveland Clinic

rodrigf3@ccf.org

215 444-9950

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Locations

US (2)