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Clinical Trials/NCT05735132
NCT05735132Active, not recruitingNot Applicable

A Randomized Controlled Trial Comparing the Effects of Conventional, Bar-shaped, and V-shaped Local Infiltration Anesthesia on Pain Relief and Cannulation Success Rate in Patients Requiring Radial Artery Cannulation.

First People's Hospital of Chenzhou1 site in 1 country180 target enrollmentStarted: February 5, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
Success rate of radial artery cannulation

Study Overview

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.

Detailed Description

The purpose of the study, as well as the necessity, benefits, and risks of arterial cannulation, and the purpose of the study, were explained in detail to all participants screened by inclusion and exclusion criteria, and signed informed consent was obtained on the day before the operation.

Upon entering the operating room, participants will be connected to a pulse oximeter, noninvasive blood pressure monitor, and electrocardiograph and will record baseline heart rate, blood pressure, depth of the radial artery at the first wrist stripe before local anesthesia, and PVDF capacitance difference.

The arterial pressure transducer and tubing will be flushed with 25 U/mL of heparin saline and kept in a ready state.

Anesthesiologists not participating in the study will then be asked to open an opaque sealed envelope to determine the type of local anesthesia to be used during intubation. The conventional approach is to complete a 2 cm subcutaneous injection with 2% lidocaine directly above the artery in the direction of the palpable beat; the bar-blocking is to complete a 2 cm subcutaneous injection perpendicular to the arterial beat line 2 cm from the proximal segment of the puncture site, and the V-blocking is to complete a subcutaneous injection at a 90-degree angle with a 2-cm margin toward the distal end at 2 cm proximal to the puncture site. Heart rate, blood pressure, depth of the radial artery at the first wrist stripe, and PVDF capacitance difference were recorded at the end of local anesthesia.

The radial artery cannula will be placed with a 20 gauge radial artery catheter by palpation under the supervision of an anesthesia consultant in the operating room by another anesthesiology resident not involved in the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Success rate of radial artery cannulation

Time Frame: upto 3 months

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

VAS score

Time Frame: upto 10 minutes

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) .

Time spent on radial artery cannulation

Time Frame: upto 5 minutes

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

Secondary Outcomes

  • Polyvinylidene fluoride (PVDF) capacitance difference(upto 5 minutes)
  • Heart rate(upto 5 minutes)
  • Depth of tested radial artery(upto 5 minutes)
  • Blood Pressure(upto 5 minutes)

Investigators

Sponsor
First People's Hospital of Chenzhou
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yi Zhang

Principal Investigator

First People's Hospital of Chenzhou

Study Sites (1)

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