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

NCT ID: NCT06838572

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-09-01

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.

Detailed Description

Arterial puncture is a common cause of iatrogenic pain and anxiety, which can lead to stress and arterial spasm, leading to puncture failure.Clinicians usually use pharmacology to treat acute pain, but it is often accompanied by circulatory and respiratory depression, abnormal coagulation function, edema, pruritus, nausea, vomiting, constipation, addiction, etc., which can lead to death, and doctors strictly restrict the use of indications.In addition to drugs, electrical, light, mechanical or thermal stimulation can produce local reversible blocking effect of the peripheral nerve.Temperature is a simple, controllable and reversible physical factor.Current studies have shown that cooling the peripheral nerve to 10-15°C for 10 minutes can relieve pain, and numbness can occur after 15 minutes.These results suggest that cooling the peripheral nerve of sensory innervation in the remote trauma area can reduce nerve conduction velocity and signal amplitude, and provide a new method for non-pharmaceutical analgesia.Local peripheral nerve cooling therapy is an attractive approach to blocking nociceptive information because it is non-addictive, reversible, and allows simultaneous electrophysiological monitoring of the blocked nerve.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 pain stimulation, and provide a new nonpharmaceutical analgesic mode for clinical.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Skin cooling to 20°C

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.

Group Type: EXPERIMENTAL

Skin cooling to 20°C

Intervention Type: 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 15°C

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.

Group Type: EXPERIMENTAL

Skin cooling to 15°C

Intervention Type: 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 8°C

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.

Group Type: EXPERIMENTAL

Skin cooling to 8°C

Intervention Type: 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.

No skin cooling

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.

Group Type: PLACEBO_COMPARATOR

No skin cooling

Intervention Type: 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.

Interventions

Skin cooling to 20°C

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.

Intervention Type: PROCEDURE

Skin cooling to 15°C

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.

Intervention Type: PROCEDURE

Skin cooling to 8°C

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.

Intervention Type: PROCEDURE

No skin cooling

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 18 ~ 65 years old;

2. ASA I-II level;

3. Patients with perioperative invasive arterial blood pressure monitoring;

4. Right-handed;

5. Allen test was normal (palm color quickly turned red or returned to normal within 10 seconds after release of ulnar artery pressure);

6. Participate voluntarily and be able to understand and sign informed consent.

Exclusion Criteria

1. Patients with a history of musculoskeletal, vascular, neurological or psychiatric disorders;

2. Patients with a history of diabetes or other systemic diseases

3. Patients who used any analgesic medication within the month before and during the study;

4. Patients with a history of smoking, alcohol or drug addiction;

5. Paraesthesia, scar, redness, damage, rash, etc. exist in the skin of the patient in the test area;

6. Patients whose surgical area overlaps with the cooling treatment or puncture area;

7. Female subjects are menstruating.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

He Huang, ph.D

Role: STUDY_CHAIR

The Second Affiliated Hospital, Chongqing Medical University

Locations

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, ph.D

Role: CONTACT

huanghe@cqmu.edu.cn

86+13708385559

Rui Lyu

Role: CONTACT

2023440067@stu.cqmu.edu.cn

86+18580178360

Facility Contacts

He Huang, ph.D

Role: primary

huanghe@cqmu.edu.cn

86+13708385559

Other Identifiers

HH123

Identifier Type: -

Identifier Source: org_study_id