Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block (TapBlock)

July 13, 2017 updated by: Colette Curtis MD

Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial

The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.

The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown
  • Patients willing and able to provide written informed consent

Exclusion Criteria:

  • Patients less than 18 years of age, since Exparel has not been studied in this age group
  • Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child
  • Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia
  • Patients with liver dysfunction, since bupivacaine is hepatically metabolized
  • Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy
  • Patients with allergy to one of the study drugs
  • Patients with local infection, which may be exacerbated by dexamethasone
  • Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer
  • Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1-Exparel
Bupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure
Drug: Bupivacaine Extended-Release Liposome Injection (Exparel)
266mg/30mL of Exparel will be injected via unilateral TAP block
Drug: IV Acetaminophen
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
Drug: Oral Acetaminophen
Oral acetaminophen 650 mg every 6 hours.
Active Comparator: Group 2-Bupivacaine and Dexamethasone IV
Bupivacaine and Dexamethasone Injection will be administered via TAP block procedure.
Drug: IV Acetaminophen
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
Drug: Oral Acetaminophen
Oral acetaminophen 650 mg every 6 hours.
Drug: Bupivacaine and Dexamethasone Injection
As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Opioid Consumption
Time Frame: Post Surgery (Up to 72 Hours)
The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
Post Surgery (Up to 72 Hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Visual Analogue Scale (VAS) Pain Score at Rest
Time Frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Visual Analogue Scale (VAS) Pain Score With Movement
Time Frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Post-Surgery 24 Hours, 48 Hours, 72 Hours
Mean Time of First Opioid Use
Time Frame: Post-surgery (Up to 72 Hours)
The time of first opioid use after surgery will be recorded for up to 72 hours.
Post-surgery (Up to 72 Hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colette Curtis MD

Investigators

  • Principal Investigator: Colette Curtis, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 6, 2015

Study Completion (Actual)

June 6, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00071635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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