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TAP Blocks vs. IV Lidocaine for Kidney Transplants

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transversus Abdominis Plane Block
Intravenous Lidocaine
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block

IV Lidocaine

Arm Description

Single-injection transversus abdominis plane block

Continuous intravenous lidocaine infusion

Outcomes

Primary Outcome Measures

Opioid Consumption
Total opioid utilization

Secondary Outcome Measures

Pain Scores
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Opioid Consumption
Total opioid utilization
Opioid-Related Adverse Events
Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation
Block/Infusion-Related Adverse Events
Local Anesthetic Systemic Toxicity
Opioid Usage
Use of prescribed opioids

Full Information

First Posted
February 14, 2019
Last Updated
July 15, 2019
Sponsor
Benaroya Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03843879
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Active Comparator
Arm Description
Single-injection transversus abdominis plane block
Arm Title
IV Lidocaine
Arm Type
Active Comparator
Arm Description
Continuous intravenous lidocaine infusion
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Other Intervention Name(s)
TAP Block
Intervention Description
Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine
Intervention Type
Drug
Intervention Name(s)
Intravenous Lidocaine
Other Intervention Name(s)
Continuous intravenous lidocaine
Intervention Description
Continuous intravenous lidocaine infusion
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Total opioid utilization
Time Frame
0-24 Hours
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time Frame
0-48 Hours
Title
Opioid Consumption
Description
Total opioid utilization
Time Frame
24-48 Hours
Title
Opioid-Related Adverse Events
Description
Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation
Time Frame
0-48 Hours
Title
Block/Infusion-Related Adverse Events
Description
Local Anesthetic Systemic Toxicity
Time Frame
0-48 Hours
Title
Opioid Usage
Description
Use of prescribed opioids
Time Frame
30 days from discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil A Hanson, MD
Phone
206-223-6980
Email
neil.hanson@virginiamason.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wyndam M Strodtbeck, MD
Phone
206-223-6980
Email
wyndam.strodtbeck@virginiamason.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Hanson, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil A Hanson, MD
Email
neil.hanson@virginiamason.org
First Name & Middle Initial & Last Name & Degree
Wyndam M Strodtbeck, MD
Email
wyndam.strodtbeck@virginiamason.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34417343
Citation
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.
Results Reference
derived

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TAP Blocks vs. IV Lidocaine for Kidney Transplants

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