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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03843879
Other study ID # IRB18-109
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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