Clinical study on physiological indicators of intraoperative pain during local anesthesia surgery

JRCT ID: jRCT1052210076

Registered date:05/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: All types of pain
• Date of first enrollment: 05/09/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Thermal stimulation
The experimental thermal stimuli of 36 degrees to 50 degrees are applied to the forearm of the research subject using the thermal stimulator.

Ischemic condition
The ischemic condition is induced by the exercise such as bending and
stretching of the fingers or ankle of the research subject, with the
bag-shaped belt for blood pressure measurement wrapped and inflated
around the upper arm or thigh.

Outcome(s)

• Primary Outcome: Electroencephalogram-based pain scores

Secondary Outcome

Numerical Rating Scale, Visual Analogue Scale, Current value from Pain Vision
Value of SFMPQ-2, Pulse rate, Pulse wave amplitude, Skin conductance response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Age: patients over 20 at the time of acquiring consent
2.Gender: male and female
3.Patients who are scheduled for local anesthesia surgery
4.Patients who have consented to particpate in this study after receiving sufficient explanation for this study and gained sufficient understandings

• Exclude criteria: A patient who was judged as inappropriate as a research subject by the research director

Related Information

• Primary Sponsor: Kunihiro Nakai
• Secondary Sponsor: PaMeLa Inc.