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TAP Blocks vs. IV Lidocaine for Kidney Transplants

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ClinicalTrials.gov Identifier: NCT03843879
Recruitment Status : Unknown
Verified July 2019 by Neil Hanson, Benaroya Research Institute.
Recruitment status was:  Recruiting
First Posted : February 18, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Neil Hanson, Benaroya Research Institute

Study Description
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Brief Summary:
This study will compare continuous intravenous lidocaine against single-injection transversus abdominis plane (TAP) block as a modality for postoperative analgesia in kidney transplant surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Transversus Abdominis Plane Block Drug: Intravenous Lidocaine Phase 2 Phase 3

Detailed Description:
This study is a non-inferiority trial designed to assess the analgesic efficacy of an intravenous (IV) lidocaine infusion against single-injection transversus abdominis plane (TAP) block in patients undergoing kidney transplant surgery. The investigators propose a study of 124 subjects randomized into two groups. The control group will receive a TAP block. The study group will receive a continuous IV lidocaine infusion. The investigators hypothesize that there will be no statistically significant difference in postoperative opioid consumption between the two groups in the first 24 hours.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TAP Block
Single-injection transversus abdominis plane block
 Procedure: Transversus Abdominis Plane Block
Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine
Other Name: TAP Block
Active Comparator: IV Lidocaine
Continuous intravenous lidocaine infusion
 Drug: Intravenous Lidocaine
Continuous intravenous lidocaine infusion
Other Name: Continuous intravenous lidocaine


Outcome Measures
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Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 0-24 Hours ]
    Total opioid utilization


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 0-48 Hours ]
    Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

  2. Opioid Consumption [ Time Frame: 24-48 Hours ]
    Total opioid utilization

  3. Opioid-Related Adverse Events [ Time Frame: 0-48 Hours ]
    Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation

  4. Block/Infusion-Related Adverse Events [ Time Frame: 0-48 Hours ]
    Local Anesthetic Systemic Toxicity

  5. Opioid Usage [ Time Frame: 30 days from discharge ]
    Use of prescribed opioids


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kidney transplant recipient
  • >18 years old
  • Consent to participate

Exclusion Criteria:

  • <18 years old
  • Refusal to participate
  • Chronic opioid use
  • Seizure disorder
  • Allergy to local anesthestics
  • Severe hepatic disease
Contacts and Locations
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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): NCT03843879


Contacts
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Contact: Neil A Hanson, MD 206-223-6980 neil.hanson@virginiamason.org
Contact: Wyndam M Strodtbeck, MD 206-223-6980 wyndam.strodtbeck@virginiamason.org

Locations
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United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Neil A Hanson, MD       neil.hanson@virginiamason.org   
Contact: Wyndam M Strodtbeck, MD       wyndam.strodtbeck@virginiamason.org   
Sponsors and Collaborators
Benaroya Research Institute
Investigators
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Principal Investigator: Neil A Hanson, MD Virginia Mason Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Neil Hanson, Anesthesiologist, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT03843879    
Other Study ID Numbers: IRB18-109
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action