Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture

NCT06838572 | Recruiting DMC

• 1 other identifier: HH123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from the wound, and provide a new nonpharmaceutical analgesic mode for clinical.

Conditions

Acute Pain

Keywords

Skin cooling; arterial puncture; analgesia

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Pain Scale (VAS) score of arterial puncture procedure

  The larger values of the Visual Analogue Pain Scale (VAS) score of local anesthetic injection and the Visual Analogue Pain Scale (VAS) score of arterial puncture catheterization were taken as the Visual Analogue Pain Scale (VAS) score of the process of arterial puncture catheterization.(VAS ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable)

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

Secondary Outcomes (23)

• Pressure pain threshold

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

• Pressure pain tolerance

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

• The average perfusion

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

• The median perfusion

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

• The maximum perfusion

  From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.

Study Arms (4)

Skin cooling to 20°C

EXPERIMENTAL

The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 20°C for 15 minutes. After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery. After local anesthesia, right radial artery puncture catheterization was performed. Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.

Procedure: Skin cooling to 20°C

Skin cooling to 15°C

EXPERIMENTAL

The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 15°C for 15 minutes. After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery. After local anesthesia, right radial artery puncture catheterization was performed. Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.

Procedure: Skin cooling to 15°C

Skin cooling to 8°C

EXPERIMENTAL

The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 8°C for 15 minutes. After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery. After local anesthesia, right radial artery puncture catheterization was performed. Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.

Procedure: Skin cooling to 8°C

No skin cooling

PLACEBO COMPARATOR

The superficial skin of the right brachial plexus does not need to be cooled. After waiting 15 minutes, 1ml2% lidocaine was injected into the superficial skin of the right radial artery. After local anesthesia, right radial artery puncture catheterization was performed. There is no need to warm the radial artery after catheterization.

Procedure: No skin cooling

Interventions

Skin cooling to 20°C PROCEDURE

According to the group, copper parts at a constant temperature of 20°C were placed on the superficial skin of the brachial plexus for 15 minutes.

Skin cooling to 20°C

Skin cooling to 15°C PROCEDURE

According to the group, copper parts at a constant temperature of 15°C were placed on the superficial skin of the brachial plexus for 15 minutes.

Skin cooling to 15°C

Skin cooling to 8°C PROCEDURE

According to the group, copper parts at a constant temperature of 8°C were placed on the superficial skin of the brachial plexus for 15 minutes.

Skin cooling to 8°C

No skin cooling PROCEDURE

According to the group, copper parts at room temperature (23°C) were placed on the superficial skin of the brachial plexus for 15 minutes.

No skin cooling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 65 years old;
• ASA I-II level;
• Patients with perioperative invasive arterial blood pressure monitoring;
• Right-handed;
• Allen test was normal (palm color quickly turned red or returned to normal within 10 seconds after release of ulnar artery pressure);
• Participate voluntarily and be able to understand and sign informed consent.

You may not qualify if:

• Patients with a history of musculoskeletal, vascular, neurological or psychiatric disorders;
• Patients with a history of diabetes or other systemic diseases
• Patients who used any analgesic medication within the month before and during the study;
• Patients with a history of smoking, alcohol or drug addiction;
• Paraesthesia, scar, redness, damage, rash, etc. exist in the skin of the patient in the test area;
• Patients whose surgical area overlaps with the cooling treatment or puncture area;
• Female subjects are menstruating.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 4000000, China

RECRUITING

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• He Huang, ph.D

  The Second Affiliated Hospital, Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

He Huang, ph.D

CONTACT

86+13708385559; huanghe@cqmu.edu.cn

Rui Lyu

CONTACT

86+18580178360; 2023440067@stu.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, patient-assessor blinded

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 20, 2025
• Study Start: February 15, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)