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History of Changes for Study: NCT03843879
TAP Blocks vs. IV Lidocaine for Kidney Transplants
Latest version (submitted July 15, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 15, 2019 None (earliest Version on record)
2 July 15, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
Comparison Format:

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Study NCT03843879
Submitted Date:  February 15, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB18-109
Brief Title: TAP Blocks vs. IV Lidocaine for Kidney Transplants
Official Title: A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Not yet recruiting
Study Start: March 1, 2019
Primary Completion: March 1, 2021 [Anticipated]
Study Completion: September 1, 2021 [Anticipated]
First Submitted: February 14, 2019
First Submitted that
Met QC Criteria:
February 15, 2019
First Posted: February 18, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
February 15, 2019
Last Update Posted: February 18, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Benaroya Research Institute
Responsible Party: Principal Investigator
Investigator: Neil Hanson
Official Title: Anesthesiologist
Affiliation: Benaroya Research Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Postoperative Pain
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 124 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • TAP Block
Active Comparator: IV Lidocaine
Continuous intravenous lidocaine infusion
Drug: Intravenous Lidocaine
Continuous intravenous lidocaine infusion
Other Names:
  • Continuous intravenous lidocaine
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Neil A Hanson, MD
Telephone: 206-223-6980
Email: neil.hanson@virginiamason.org
Central Contact Backup: Wyndam M Strodtbeck, MD
Telephone: 206-223-6980
Email: wyndam.strodtbeck@virginiamason.org
Locations: United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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