Novel Local Infiltration Anesthesia for Radial Artery Cannulation.

NCT05735132 | Unknown DMC

• 1 other identifier: 2018012
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare the pain scores and cannulation success rates of conventional, bar-shaped, and V-shaped local infiltration anesthesia in participants' radial artery cannulation. The main questions it aims to answer are:

• Are bar-shaped and V-shaped more successful than the conventional block in radial artery cannulation?
• Are bar-shaped and V-shaped less painful than the conventional block in radial artery cannulation? Participants will describe their pain score during their radial artery cannulation. Researchers will compare the pain scores and cannulation success rates in bar-shaped, V-shaped, and conventional line blocking to see if bar-shaped and V-shaped blocking is better choices than conventional line blocking.

Conditions

Efficiency and Safey of Radial Artery Cannulation

Keywords

Radial Artery; Local Anesthesia; Cannulation

Outcome Measures

Primary Outcomes (3)

• VAS score

  The visual analogue scale (VAS) will evaluate pain intensity during radial artery cannulation. This scale is a 10-cm horizontal line with terminal descriptors of 0 (no pain) and 10 (worst imaginable pain) .

  upto 10 minutes

• Time spent on radial artery cannulation

  From the completion of local infiltration anesthesia to the completion of radial artery cannulation, up to 15 minutes.

  upto 5 minutes

• Success rate of radial artery cannulation

  Success rate will be recorded to evaluate the influences of local anesthesia to radial artery cannulation.

  upto 3 months

Secondary Outcomes (4)

• Depth of tested radial artery

  upto 5 minutes

• Polyvinylidene fluoride (PVDF) capacitance difference

  upto 5 minutes

• Heart rate

  upto 5 minutes

• Blood Pressure

  upto 5 minutes

Study Arms (3)

Line arm

ACTIVE COMPARATOR

Conventional line blocking is used in radial artery cannulation for local infiltration.

Procedure: Conventional Line-blocking

Bar arm

EXPERIMENTAL

Bar-blocking is used in radial artery cannulation for local infiltration.

Procedure: Bar-blocking

V arm

EXPERIMENTAL

V-blocking is used in radial artery cannulation for local infiltration.

Procedure: V-blocking

Interventions

Conventional Line-blocking PROCEDURE

Participants will receive a 2 cm subcutaneous 1% lidocaine local infiltration injection parallel to the arm at the puncture site.

Also known as: lidocaine infiltration at the point

Line arm

Bar-blocking PROCEDURE

Participants will receive a bar-shaped subcutaneous 1% lidocaine local infiltration injection in the vertical arm, 2 cm away from the puncture site.

Also known as: lidocaine infiltration with a cross bar

Bar arm

V-blocking PROCEDURE

Participants will receive a V-shaped subcutaneous 1% lidocaine local infiltration injection at a 90-degree angle 2 cm away from the puncture site.

Also known as: lidocaine infiltration with v shape

V arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is scheduled for elective surgery.
• The participant's elective surgery required radial artery cannulation.
• Participants should be at least 18 years old.

You may not qualify if:

• The Allen test of the participant is negative.
• The participant has a history of peripheral vascular disease.
• The participant has a cannula site infection or lesion.
• The participant is on vasoactive medication.
• A history of artery cannulation at the planned cannulation site within the past month.

Sponsors & Collaborators

• First People's Hospital of Chenzhou: lead

Study Sites (1)

Chenzhou First People's Hospital

Chenzhou, Hunan, 423400, China

Location

Study Officials

• Bin Zeng, Master

  First People's Hospital of Chenzhou

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: February 21, 2023
• Study Start: February 5, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)