An observational study on thel stress of awake nerve block on patients

JRCT ID: jRCT1010240002

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing upper and lower extremity surgery at Sapporo Medical University Hospital
• Date of first enrollment: 01/04/2024
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: Stress response during nerve block (STAI and salivary amylase levels)

Secondary Outcome

Comparison of Percentage Change in Salivary Amylase Levels Before and After Upper and Lower Extremity Nerve Blocks
Comparison of Maximum Systolic Blood Pressure During Upper and Lower Extremity Nerve Blocks
Comparison of Maximum Diastolic Blood Pressure During Upper and Lower Extremity Nerve Blocks
Comparison of maximal heart rate during nerve block for upper and lower extremity nerve blocks
Comparison of Pain Rating (VAS) during Upper and Lower Extremity Nerve Blocks
Correlation of preoperative STAI and percent change in salivary amylase levels during upper and lower extremity nerve blocks
Correlation of preoperative STAI with maximum systolic blood pressure during upper and lower extremity nerve blocks
Correlation of preoperative STAI with maximal diastolic blood pressure in upper and lower extremity nerve blocks
Correlation between preoperative STAI and maximum heart rate in upper and lower extremity nerve blocks
Correlation between preoperative STAI and VAS in upper and lower extremity nerve blocks
Correlation Between Preoperative STAI and Heart Rate Variability Analysis in Upper and Lower Extremity Nerve Blocks

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients over 18 years of age undergoing surgery at Sapporo Medical University Hospital and receiving the targeted nerve blocks (upper extremity: brachial plexus block interscalene, supraclavicular and axillary approaches; lower extremity: femoral nerve block, adductor canal block, iliopsoas nerve block and sciatic nerve block, popliteal approach).
• Exclude criteria: Patients with coagulopathy, peripheral neuropathy such as diabetes mellitus, infection at the site of administration, pregnancy, mental disorders, patients with cognitive problems, salivary amylase level of 46 kU/I or higher on admission, patients with very high anxiety on admission, and other patients deemed inappropriate for this study by the anesthesiologists. In addition, patients whose salivary amylase level on admission is 46 kU/I or higher and who are very anxious on admission.

Related Information

• Primary Sponsor: Yamakage Michiaki