## Protocol Section
### Identification Module
**NCT ID:** NCT06424145

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 19981228
#### Organization
**Class:** OTHER
**Full Name:** Sichuan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ting Xu

#### Responsible Party

**Investigator Affiliation:** Sichuan Provincial People's Hospital

**Investigator Full Name:** Ting Xu

**Investigator Title:** Chief physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Radial Artery Injury

**Keywords:**

- Puncture site of radial artery

- Lidocaine injection

- Success ratio

- Invasive blood pressure measurement

- Radial artery puncture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 216

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Injection of 1% lidocaine 1 ml above the artery

**Intervention Names:**

- Diagnostic Test: Superior radial artery

**Label:** Superior group of radial artery

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Injection of 1% lidocaine 1 ml to the right side of the artery

**Intervention Names:**

- Diagnostic Test: Right side of radial artery

**Label:** Right radial artery group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Superior group of radial artery

**Description:** Upper radial artery, 1 ml of lidocaine

**Name:** Superior radial artery

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Right radial artery group

**Description:** Right side of the radial artery,1ml of lidocaine

**Name:** Right side of radial artery

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** What is the probability of success the first time?

**Measure:** Success ratio of first radial artery puncture

**Time Frame:** Day 1

#### Secondary Outcomes

**Description:** In millimeters, Increase or decrease

**Measure:** 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

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chengdu

**Country:** China

**Facility:** Sichuan provincial Peopel'Hospital

**State:** Sichuan

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
