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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

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
Opioid Consumption [ Time Frame: 0-24 Hours ]
Total opioid utilization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • 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)
  • Opioid Consumption [ Time Frame: 24-48 Hours ]
    Total opioid utilization
  • Opioid-Related Adverse Events [ Time Frame: 0-48 Hours ]
    Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation
  • Block/Infusion-Related Adverse Events [ Time Frame: 0-48 Hours ]
    Local Anesthetic Systemic Toxicity
  • Opioid Usage [ Time Frame: 30 days from discharge ]
    Use of prescribed opioids
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TAP Blocks vs. IV Lidocaine for Kidney Transplants
Official Title  ICMJE A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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
  • Drug: Intravenous Lidocaine
    Continuous intravenous lidocaine infusion
    Other Name: Continuous intravenous lidocaine
Study Arms  ICMJE
  • Active Comparator: TAP Block
    Single-injection transversus abdominis plane block
    Intervention: Procedure: Transversus Abdominis Plane Block
  • Active Comparator: IV Lidocaine
    Continuous intravenous lidocaine infusion
    Intervention: Drug: Intravenous Lidocaine
Publications * Hanson NA, Strunk J, Saunders G, Cowan NG, Brandenberger J, Kuhr CS, Oryhan C, Warren DT, Slee AE, Strodtbeck W. Comparison of continuous intravenous lidocaine versus transversus abdominis plane block for kidney transplant surgery: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2021 Nov;46(11):955-959. doi: 10.1136/rapm-2021-102973. Epub 2021 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2019)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843879
Other Study ID Numbers  ICMJE IRB18-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neil Hanson, Benaroya Research Institute
Study Sponsor  ICMJE Benaroya Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neil A Hanson, MD Virginia Mason Medical Center
PRS Account Benaroya Research Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP