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

NCT ID: NCT06424145

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-01-01

Brief 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.

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.

Conditions

Radial Artery Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Superior group of radial artery

Injection of 1% lidocaine 1 ml above the artery

Group Type: EXPERIMENTAL

Superior radial artery

Intervention Type: DIAGNOSTIC_TEST

Upper radial artery, 1 ml of lidocaine

Right radial artery group

Injection of 1% lidocaine 1 ml to the right side of the artery

Group Type: EXPERIMENTAL

Right side of radial artery

Intervention Type: DIAGNOSTIC_TEST

Right side of the radial artery,1ml of lidocaine

Interventions

Superior radial artery

Upper radial artery, 1 ml of lidocaine

Intervention Type: DIAGNOSTIC_TEST

Right side of radial artery

Right side of the radial artery,1ml of lidocaine

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ting Xu

OTHER

Sponsor Role: lead

Responsible Party

Ting Xu

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sichuan provincial Peopel'Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

19981228

Identifier Type: -

Identifier Source: org_study_id