Effect of yokukansan in the perioperative period

Phase 2

Recruiting

• Conditions: breast cancer; D001943

• Registration Number: JPRN-jRCT1031190049
• Lead Sponsor: Baba Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Patients who are diagnosed with breast cancer and who undergo total mastectomy and sentinel lymph node biopsy, partial mastectomy and sentinel lymph node biopsy at Niigata University Medical and Dental Hospital and Niigata Cancer Center.
2. Patients who received written and oral explanations on this study and who showed consent to participate in writing.

Exclusion Criteria

1. If the subject's consent cannot be obtained.
2. The patients whose physical status classification of American Society of Anesthesiology are (ASA - PS) 4 or more.
3. The patients whose BMI (Body Mass Index) are more than 30
4. Patients who already have pain anywhere in the body except for the original disease.
5. The patients who are allergic to the drugs used in this study.
6. The patients with hypokalemia.
7. The patients who take anxiolytics or psychotropic drug.
8. The patients already using analgesics including opioids.
9. The patients who are difficult to communicate (dementia, mental retardation, mental illness, not understanding Japanese).
10. The patients who are judged inappropriate by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary amylase value

Secondary Outcome Measures

Name	Time	Method
Hospital anxiety and depression scale: HADS, State Trait Anxiety Inventory:STAI, Quality of Recovery:QOR, visual analog scele:VAS of pain