Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatments bupivacaine, exparel®, ropivacaine
Phase phase 3
Sponsor Joshua Herskovic
Start date November 2015
End date October 2018
Trial size 90 participants
Trial identifier NCT02652156, MZ2014035

Summary

This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
bupivacaine Marcaine
60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
(Active Comparator)
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
exparel® bupivacaine liposome injectable suspension
20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
(Active Comparator)
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
ropivacaine Naropin
40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.

Primary Outcomes

Measure
Total dosage of narcotic
time frame: 3 postoperative days

Secondary Outcomes

Measure
Postoperative vomiting (events)
time frame: 3 postoperative days
Patient reported pain by VAS scale
time frame: Postoperative Day 1
Patient reported pain by VAS scale
time frame: Postoperative Day 2
Patient reported pain by VAS scale
time frame: Postoperative Day 3
Number of days required for a patient to get out of bed
time frame: Assessed daily for up to 3 days post-surgery
Number of days required for a patient to walk unassisted
time frame: Assessed daily for up to 3 days post-surgery

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ability to give written informed consent - Scheduled for open abdominal surgery - American Society of Anesthesiologists physical status 1 to 3 Exclusion Criteria: - Inability to understand the study or provide written informed consent - Inability to follow protocol instructions - Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery - Allergy to local anesthetic agents - Contraindication to regional nerve block such as: - Bleeding disorder - Sepsis - Infection at site of block - Body Mass Index (BMI) >40 - Pregnancy

Additional Information

Official title Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
Principal investigator Joshua Herskovic, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Midwestern Regional Medical Center.