Clinical trial NCT06424145: Effect of Local Anesthesia Position of Lidocaine Injection on the Success Rate of Radial Artery Puncture Tube
Official title: A Single-center, Randomized and Controlled Clinical Research Projects
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Radial Artery Injury
Keywords: Puncture site of radial artery
Lidocaine injection
Success ratio
Invasive blood pressure measurement
Radial artery puncture
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Success ratio of first radial artery puncture
timeFrame: Day 1
Secondary outcomes:
measure: Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes
timeFrame: Day 1
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan provincial Peopel'Hospital
state: Sichuan
Study officials:
References: