TAP Block for Postoperative Pain Control

Phase 3

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: Exparel®; Drug: Bupivacaine; Drug: Ropivacaine

• Registration Number: NCT02652156
• Lead Sponsor: Joshua Herskovic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Primary Completion: 2016-04-16
• Study Completion: 2016-04-16
• Status Verified: 2018-10
• Results First Submitted: 2018-10-10
• Results First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Injection of Exparel®	Exparel®	Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Single Injection of Bupivacaine	Bupivacaine	Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Continuous infusion of Ropivacaine	Ropivacaine	Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump

Primary Outcome Measures

Name	Time	Method
Total Dosage of Narcotic	3 postoperative days	The total use of analgesic medications will be recorded during the 3 days immediately following surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Days Required for a Patient to Get Out of Bed	Assessed daily for up to 3 days post-surgery	Patients will be assessed each day following the day of surgery for the ability to get out of bed.
Postoperative Vomiting (Events)	3 postoperative days	Total number of vomiting episodes over the three postoperative days.
Patient Reported Pain by VAS Scale	Postoperative Day 3	Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Number of Days Required for a Patient to Walk Unassisted	Assessed daily for up to 3 days post-surgery	Patients will be assessed each day following the day of surgery for the ability to walk unassisted