TAP Block for Postoperative Pain Control

Joshua Herskovic

Status and phase: Terminated; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Ropivacaine; Drug: Exparel®; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02652156

MZ2014035

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Single Injection of Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Single Injection of Exparel®

Active Comparator group

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

Treatment:

Drug: Exparel®

Continuous infusion of Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine