Effect of Local Anesthesia Position of Lidocaine Injection on the Success Rate of Radial Artery Puncture Tube

June 5, 2024 updated by: Ting Xu

A Single-center, Randomized and Controlled Clinical Research Projects

Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan provincial Peopel'Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ASA Class I-III, patients aged 18-80 years
  2. Planned surgery with radial artery catheterization
  3. Allen test negative
  4. Sign the informed consent form and voluntarily participate in this trial

Exclusion Criteria:

  1. Inflamed skin at puncture site
  2. Extremely nervous and unable to cooperate
  3. Ultrasonographic assessment of aberrant radial artery
  4. Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
  5. The patient had undergone radial artery catheterization in the same arm in the past week
  6. History of hypersensitivity to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superior group of radial artery
Injection of 1% lidocaine 1 ml above the artery
Diagnostic test: Superior radial artery
Upper radial artery, 1 ml of lidocaine
Experimental: Right radial artery group
Injection of 1% lidocaine 1 ml to the right side of the artery
Diagnostic test: Right side of radial artery
Right side of the radial artery,1ml of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success ratio of first radial artery puncture
Time Frame: Day 1
What is the probability of success the first time?
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes
Time Frame: Day 1
In millimeters, Increase or decrease
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ting Xu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19981228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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