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

Radial Artery Injury Clinical Trial

Official title:

A Single-center, Randomized and Controlled Clinical Research Projects

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06424145
• Other study ID #: 19981228
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 216
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Radial Artery Injury

Intervention

Diagnostic Test:
• Superior radial artery
Upper radial artery, 1 ml of lidocaine
• Right side of radial artery
Right side of the radial artery,1ml of lidocaine

Locations

Country	Name	City	State
China	Sichuan provincial Peopel'Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Ting Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success ratio of first radial artery puncture	What is the probability of success the first time?	Day 1
Secondary	Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes	In millimeters, Increase or decrease	Day 1