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

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ClinicalTrials.gov Identifier: NCT02179892
Recruitment Status : Terminated (Inadequate patient population to complete enrollment)
First Posted : July 2, 2014
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Colette Curtis MD, Emory University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Extended-Release Liposome Injection (Exparel) Drug: Bupivacaine and Dexamethasone Injection Drug: IV Acetaminophen Drug: Oral Acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : June 6, 2015
Actual Study Completion Date : June 6, 2015


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: 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.

Drug: IV Acetaminophen
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.

Drug: Oral Acetaminophen
Oral acetaminophen 650 mg every 6 hours.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179892


Locations
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United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Colette Curtis MD
Investigators
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Principal Investigator: Colette Curtis, MD Emory University

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Responsible Party: Colette Curtis MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02179892    
Other Study ID Numbers: IRB00071635
First Posted: July 2, 2014    Key Record Dates
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Colette Curtis MD, Emory University:
anesthesia
surgery
pain
Additional relevant MeSH terms:
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Acetaminophen
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics