TAP Blocks vs. IV Lidocaine for Kidney Transplants

Phase 2

• Conditions: Postoperative Pain
• Interventions: Procedure: Transversus Abdominis Plane Block; Drug: Intravenous Lidocaine

• Registration Number: NCT03843879
• Lead Sponsor: Benaroya Research Institute

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 Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-04-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block	Transversus Abdominis Plane Block	Single-injection transversus abdominis plane block
IV Lidocaine	Intravenous Lidocaine	Continuous intravenous lidocaine infusion

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	0-24 Hours	Total opioid utilization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States