Effect of Local Anesthesia Position of Lidocaine Injectio... | NCT06424145

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

NCT06424145

Sponsor

Ting Xu

Status

Unknown status

Last Update Posted

Jun 6, 2024Actual

Enrollment

216Estimated

Phase

Not Applicable

Conditions

Radial Artery Injury

Interventions

Superior radial artery
Right side of radial artery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2024Estimated

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

May 1, 2024

First Submission Date that Met QC Criteria

May 20, 2024

First Posted Date

May 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2024

Last Update Posted Date

Jun 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Superior group of radial artery	Experimental	Injection of 1% lidocaine 1 ml above the artery	Diagnostic Test: Superior radial artery
Right radial artery group	Experimental	Injection of 1% lidocaine 1 ml to the right side of the artery	Diagnostic Test: Right side of radial artery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Superior radial artery	Diagnostic Test	Upper radial artery, 1 ml of lidocaine	Superior group of radial artery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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	In millimeters, Increase or decrease	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inflamed skin at puncture site
Extremely nervous and unable to cooperate
Ultrasonographic assessment of aberrant radial artery
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)
The patient had undergone radial artery catheterization in the same arm in the past week
History of hypersensitivity to local anesthetics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan provincial Peopel'Hospital		Chengdu	Sichuan		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided