Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
Overview
- Phase
- Phase 3
- Intervention
- Bupivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Joshua Herskovic
- Enrollment
- 14
- Primary Endpoint
- Total Dosage of Narcotic
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Joshua Herskovic
Anesthesiologist
Midwestern Regional Medical Center
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
- •Infection at site of block
- •Body Mass Index (BMI) \>40
- •Pregnancy
Arms & Interventions
Single Injection of Bupivacaine
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Intervention: Bupivacaine
Single Injection of 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
Intervention: Exparel®
Continuous infusion of Ropivacaine
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Intervention: Ropivacaine
Outcomes
Primary Outcomes
Total Dosage of Narcotic
Time Frame: 3 postoperative days
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
Secondary Outcomes
- Number of Days Required for a Patient to Get Out of Bed(Assessed daily for up to 3 days post-surgery)
- Postoperative Vomiting (Events)(3 postoperative days)
- Patient Reported Pain by VAS Scale(Postoperative Day 3)
- Number of Days Required for a Patient to Walk Unassisted(Assessed daily for up to 3 days post-surgery)