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

Not Applicable

Not yet recruiting

• Conditions: Acute Pain

• Registration Number: NCT06838572
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-09
• Study Start: 2025-02-15
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale (VAS) score of arterial puncture procedure	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	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)

Secondary Outcome Measures

Name	Time	Method
Pressure pain threshold	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the start of cooling therapy, 5 minutes into cooling therapy, 15 minutes after the start of cooling therapy, and 10 minutes after rewarming, the handheld algometer is used to measure the Pressure Pain Threshold (PPT) at the following locations: The midpoint of the ulna and radius at the wrist joint of both forearms (as bony pressure pain points) The brachioradialis muscle on the lateral side of the forearm (as muscular pressure pain points) Unit: Kilograms-force per square centimeter (kg/cm²)
Pressure pain tolerance	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the start of cooling therapy, 5 minutes into cooling therapy, 15 minutes after the start of cooling therapy, and 10 minutes after rewarming, the handheld algometer is used to measure the Pressure Pain Tolerance (PTO) at the aforementioned locations.; Unit: Kilograms-force per square centimeter (kg/cm²)
The average perfusion	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the administration of local anesthesia, during the process of local anesthesia, after the completion of local anesthesia, before arterial puncture, during the arterial puncture procedure, and after the completion of arterial puncture, the patient is instructed to maintain a calm state and lie in a supine position with the left arm abducted. Under these conditions, the Region of Interest (ROI) is outlined using laser speckle technology, and the average perfusion of this area is measured.
The median perfusion	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the administration of local anesthesia, during the process of local anesthesia, after the completion of local anesthesia, before arterial puncture, during the arterial puncture procedure, and after the completion of arterial puncture, the patient is required to remain calm and in a supine position with the left arm abducted. Under these conditions, the Region of Interest (ROI) is outlined using laser speckle technology, and the median perfusion of this area is measured.
The maximum perfusion	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the administration of local anesthesia, during the process of local anesthesia, after the completion of local anesthesia, before arterial puncture, during the arterial puncture procedure, and after the completion of arterial puncture, the patient is required to remain calm and in a supine position with the left arm abducted. Under these conditions, the Region of Interest (ROI) is delineated using laser speckle technology, and the maximum perfusion of this area is measured.
The minimum perfusion	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Before the administration of local anesthesia, during the process of local anesthesia, after the completion of local anesthesia, before arterial puncture, during the arterial puncture procedure, and after the completion of arterial puncture, the patient is required to remain calm and in a supine position with the left arm abducted. Under these conditions, the Region of Interest (ROI) is delineated using laser speckle technology, and the minimum perfusion of this area is measured.
The approximate depth of the right brachial plexus.	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Perform ultrasound localization of the right axillary artery depth before the start of hypothermia treatment.; Unit: millimeters (mm).
Depth of the Right Radial Artery	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Place the ultrasound probe at a position 1 cm proximal to the right radial styloid process to measure the distance from the skin surface to the center of the right radial artery at the following time points:before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming.; Unit: Millimeters (mm)
Peak Systolic Velocity (PS)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The maximum blood flow velocity in the right radial artery during the systolic phase of the cardiac cycle is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, reflecting the artery's ability to transport blood.; Unit: Centimeters per second (cm/s)
Time-Averaged Mean Velocity (TAMEAN)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The average blood flow velocity in the right radial artery over a specified time interval is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, to assess changes in blood flow.; Unit: Centimeters per second (cm/s)
End Diastolic Velocity (ED)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The blood flow velocity at the end of the diastolic phase in the right radial artery is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, to assess changes in blood flow.; Unit: Centimeters per second (cm/s)
Time-Averaged Maximum Velocity (TAMAX)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The highest average blood flow velocity in the right radial artery over a specified time interval is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, to evaluate changes in blood flow.; Unit: Centimeters per second (cm/s)
Pulsatility Index (PI)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	A dimensionless index measuring changes in blood flow velocity over the cardiac cycle is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, to comprehensively assess changes in arterial vascular function and hemodynamics.
Resistance Index (RI)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The Resistance Index (RI) is measured at the following specific time points: before the start of cooling therapy, 5 minutes into the cooling therapy, 15 minutes after the start of cooling therapy, and 10 minutes after the rewarming period. This index is used to assess the resistance to blood flow within the artery and to understand changes in the blood flow status.
Systolic/Diastolic Ratio (S/D)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The ratio of systolic to diastolic blood flow velocities is calculated at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming, which helps to assess changes in hemodynamics and vascular health.
Blood Flow Volume (VolFlow)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The volume of blood flowing through the right radial artery is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, to evaluate changes in blood flow.; Unit: Milliliters per minute (mL/min)
Vessel Diameter (Vas Diam)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The internal diameter of the right radial artery is measured before the start of cooling therapy, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius to assess the width of the artery lumen.; Unit: Millimeters (mm)
Vessel Area (Vas Area)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	The cross-sectional area of the right radial artery is measured at the following time points: before the start of cooling, 5 minutes into cooling, 15 minutes after the start of cooling, and 10 minutes after rewarming. The ultrasound probe is placed 1 centimeter proximal to the styloid process of the right radius, providing an indicator of the artery's size.; Unit: Square millimeters (mm²)
Room Temperature (°C)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Measured at the following time points: before initiation of cooling therapy, 5 minutes after cooling therapy initiation, 15 minutes after cooling therapy initiation, and 10 minutes after rewarming. Unit: degrees Celsius (°C).
Skin Temperature at the Right Brachial Plexus Superficial Ice Pack Application Area (°C)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Measured at the following time points: before initiation of cooling therapy, 5 minutes after cooling therapy initiation, 15 minutes after cooling therapy initiation, and 10 minutes after rewarming. Unit: degrees Celsius (°C).
Skin Temperature at the Right Radial Artery Puncture Site (°C)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Measured at the following time points: before initiation of cooling therapy, 5 minutes after cooling therapy initiation, 15 minutes after cooling therapy initiation, and 10 minutes after rewarming. Unit: degrees Celsius (°C).
Superficial Skin Temperature at the Left Radial Artery (°C)	From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.	Measured at the following time points: before initiation of cooling therapy, 5 minutes after cooling therapy initiation, 15 minutes after cooling therapy initiation, and 10 minutes after rewarming. Unit: degrees Celsius (°C).
Complication	From 0 to 24 hours after the volunteers enter the pre-anesthesia holding area.	Observe whether there is frostbite in the remote local peripheral nerve cooling treatment, test and puncture area, and diagnose and treat frostbite as early as possible.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China