Acute PainNCT06838572
Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
A study testing Skin cooling to 20°C, Skin cooling to 15°C and Skin cooling to 8°C in people with Acute Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pain
- What is being tested?
- Skin cooling to 20°C, Skin cooling to 15°C and Skin cooling to 8°C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 ~ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 4000000
He Huang, ph.D, 86+13708385559, huanghe@cqmu.edu.cn
About this study
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.
Read the 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
- Being tested
- Skin cooling to 20°C, Skin cooling to 15°C, Skin cooling to 8°C, No skin cooling
- Keywords
- Skin cooling, arterial puncture, analgesia
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin cooling to 20°CProcedure or surgery
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°CProcedure or surgery
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°CProcedure or surgery
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 coolingProcedure or surgery
According to the group, copper parts at room temperature (23°C) were placed on the superficial skin of the brachial plexus for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: No skin cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Secondary outcomes (23)
Pressure pain threshold
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Pressure pain tolerance
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The average perfusion
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The median perfusion
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The maximum perfusion
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The minimum perfusion
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The approximate depth of the right brachial plexus.
Perform ultrasound localization of the right axillary artery depth before the start of hypothermia treatment.
Unit: millimeters (mm).
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Depth of the Right Radial Artery
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Peak Systolic Velocity (PS)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
End Diastolic Velocity (ED)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Time-Averaged Maximum Velocity (TAMAX)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Time-Averaged Mean Velocity (TAMEAN)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Pulsatility Index (PI)
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Resistance Index (RI)
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Systolic/Diastolic Ratio (S/D)
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.
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Blood Flow Volume (VolFlow)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Vessel Diameter (Vas Diam)
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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Vessel Area (Vas 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)
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Room Temperature (°C)
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).
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Skin Temperature at the Right Brachial Plexus Superficial Ice Pack Application Area (°C)
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).
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Skin Temperature at the Right Radial Artery Puncture Site (°C)
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).
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Superficial Skin Temperature at the Left Radial Artery (°C)
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).
Measured: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Complication
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.
Measured: From 0 to 24 hours after the volunteers enter the pre-anesthesia holding area.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, patient-assessor blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Huang, ph.D, Study chair, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838572
- Sponsor's protocol ID
- HH123
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
- ClinicalTrials.gov ID
- NCT06838572
- Acronym / sponsor ID
- HH123
- Conditions
- Acute Pain
- Keywords
- Skin cooling, arterial puncture, analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective, randomized, patient-assessor blinded
| Arm | Type | Receives |
|---|---|---|
| Skin cooling to 20°C | Experimental | Procedure: Skin cooling to 20°CThe 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. |
| Skin cooling to 15°C | Experimental | Procedure: Skin cooling to 15°CThe 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. |
| Skin cooling to 8°C | Experimental | Procedure: Skin cooling to 8°CThe 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. |
| No skin cooling | Placebo comparator | Procedure: No skin coolingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 18 ~ 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin cooling to 20°CAccording 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. | Procedure or surgery | Skin cooling to 20°C |
| Skin cooling to 15°CAccording 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. | Procedure or surgery | Skin cooling to 15°C |
| Skin cooling to 8°CAccording 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. | Procedure or surgery | Skin cooling to 8°C |
| No skin coolingAccording to the group, copper parts at room temperature (23°C) were placed on the superficial skin of the brachial plexus for 15 minutes. | Procedure or surgery | No skin cooling |
Primary outcome
Visual Analogue Pain Scale (VAS) score of arterial puncture procedure
Time frame: 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)
23 secondary outcomes
Pressure pain threshold
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Pressure pain tolerance
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The average perfusion
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The median perfusion
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The maximum perfusion
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The minimum perfusion
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The approximate depth of the right brachial plexus.
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Depth of the Right Radial Artery
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Peak Systolic Velocity (PS)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
End Diastolic Velocity (ED)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Time-Averaged Maximum Velocity (TAMAX)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Time-Averaged Mean Velocity (TAMEAN)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Pulsatility Index (PI)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Resistance Index (RI)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Systolic/Diastolic Ratio (S/D)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Blood Flow Volume (VolFlow)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Vessel Diameter (Vas Diam)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Vessel Area (Vas Area)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Room Temperature (°C)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Skin Temperature at the Right Brachial Plexus Superficial Ice Pack Application Area (°C)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Skin Temperature at the Right Radial Artery Puncture Site (°C)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Superficial Skin Temperature at the Left Radial Artery (°C)
Time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Complication
Time frame: From 0 to 24 hours after the volunteers enter the pre-anesthesia holding area.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
He Huang, ph.D study chair
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin cooling to 20°C, Skin cooling to 15°C and Skin cooling to 8°C in people with Acute Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang, ph.D (86+13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Scale (VAS) score of arterial puncture procedure (time frame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.