NCT03843879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

February 14, 2019

Last Update Submit

July 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    Total opioid utilization

    0-24 Hours

Secondary Outcomes (5)

  • Pain Scores

    0-48 Hours

  • Opioid Consumption

    24-48 Hours

  • Opioid-Related Adverse Events

    0-48 Hours

  • Block/Infusion-Related Adverse Events

    0-48 Hours

  • Opioid Usage

    30 days from discharge

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

Single-injection transversus abdominis plane block

Procedure: Transversus Abdominis Plane Block

IV Lidocaine

ACTIVE COMPARATOR

Continuous intravenous lidocaine infusion

Drug: Intravenous Lidocaine

Interventions

Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine

Also known as: TAP Block
TAP Block

Continuous intravenous lidocaine infusion

Also known as: Continuous intravenous lidocaine
IV Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant recipient
  • \>18 years old
  • Consent to participate

You may not qualify if:

  • \<18 years old
  • Refusal to participate
  • Chronic opioid use
  • Seizure disorder
  • Allergy to local anesthestics
  • Severe hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Neil A Hanson, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

April 1, 2019

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations