TAP Blocks vs. IV Lidocaine for Kidney Transplants

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03843879
• Other study ID #: IRB18-109
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2019
• Source: Benaroya Research Institute
• Contact: Neil A Hanson, MD
• Phone: 206-223-6980
• Email: neil.hanson[@]virginiamason.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Transversus Abdominis Plane Block
Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine

Drug:
• Intravenous Lidocaine
Continuous intravenous lidocaine infusion

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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