Clinical trial NCT06838572: Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
Official title: Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Keywords: Skin cooling
arterial puncture
analgesia
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, patient-assessor blinded
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Pain Scale (VAS) score of arterial puncture procedure
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Pressure pain tolerance
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: The average perfusion
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: The median perfusion
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: The maximum perfusion
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: The minimum perfusion
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: The approximate depth of the right brachial plexus.
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Depth of the Right Radial Artery
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Peak Systolic Velocity (PS)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: End Diastolic Velocity (ED)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Time-Averaged Maximum Velocity (TAMAX)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Time-Averaged Mean Velocity (TAMEAN)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Pulsatility Index (PI)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Resistance Index (RI)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Systolic/Diastolic Ratio (S/D)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Blood Flow Volume (VolFlow)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Vessel Diameter (Vas Diam)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Vessel Area (Vas Area)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Room Temperature (°C)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Skin Temperature at the Right Brachial Plexus Superficial Ice Pack Application Area (°C)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Skin Temperature at the Right Radial Artery Puncture Site (°C)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Superficial Skin Temperature at the Left Radial Artery (°C)
timeFrame: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
measure: Complication
timeFrame: From 0 to 24 hours after the volunteers enter the pre-anesthesia holding area.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: He Huang, ph.D
role: STUDY_CHAIR
References: