TAP Blocks vs. IV Lidocaine for Kidney Transplants

A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Transversus Abdominis Plane Block; Drug: Intravenous Lidocaine

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: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Neil A Hanson, MD; Phone Number: 206-223-6980; Email: neil.hanson@virginiamason.org
• Study Contact Backup: Name: Wyndam M Strodtbeck, MD; Phone Number: 206-223-6980; Email: wyndam.strodtbeck@virginiamason.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
      • Contact: Neil A Hanson, MD; Email: neil.hanson@virginiamason.org
      • Contact: Wyndam M Strodtbeck, MD; Email: wyndam.strodtbeck@virginiamason.org

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: TAP Block
Active Comparator: IV Lidocaine; Continuous intravenous lidocaine infusion	Drug: Intravenous Lidocaine; Continuous intravenous lidocaine infusion; Other Names: Continuous intravenous lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total opioid utilization	0-24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)	0-48 Hours
Opioid Consumption	Total opioid utilization	24-48 Hours
Opioid-Related Adverse Events	Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation	0-48 Hours
Block/Infusion-Related Adverse Events	Local Anesthetic Systemic Toxicity	0-48 Hours
Opioid Usage	Use of prescribed opioids	30 days from discharge

Collaborators and Investigators

• Sponsor: Benaroya Research Institute
• Investigators: Principal Investigator: Neil A Hanson, MD, Virginia Mason Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRB18-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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