Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control

TAP Block for Postoperative Pain Control

Sponsors

Lead sponsor: Joshua Herskovic

Source Midwestern Regional Medical Center
Brief 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.

Overall Status Terminated
Start Date November 1, 2015
Completion Date April 16, 2016
Primary Completion Date April 16, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Total Dosage of Narcotic 3 postoperative days
Secondary Outcome
Measure Time Frame
Postoperative Vomiting (Events) 3 postoperative days
Patient Reported Pain by VAS Scale Postoperative Day 1
Patient Reported Pain by VAS Scale Postoperative Day 2
Patient Reported Pain by VAS Scale Postoperative Day 3
Number of Days Required for a Patient to Get Out of Bed Assessed daily for up to 3 days post-surgery
Number of Days Required for a Patient to Walk Unassisted Assessed daily for up to 3 days post-surgery
Enrollment 14
Condition
Intervention

Intervention type: Drug

Intervention name: Bupivacaine

Description: 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.

Arm group label: Single Injection of Bupivacaine

Intervention type: Drug

Intervention name: Exparel®

Description: 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.

Arm group label: Single Injection of Exparel®

Other name: bupivacaine liposome injectable suspension

Intervention type: Drug

Intervention name: Ropivacaine

Description: 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.

Arm group label: Continuous infusion of Ropivacaine

Other name: Naropin

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Joshua Herskovic, MD Principal Investigator Midwestern Regional Medical Center
Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Joshua Herskovic

Investigator title: Anesthesiologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Single Injection of Bupivacaine

Arm group type: Active Comparator

Description: Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.

Arm group label: Single Injection of Exparel®

Arm group type: Active Comparator

Description: Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane

Arm group label: Continuous infusion of Ropivacaine

Arm group type: Active Comparator

Description: Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov