Breast Neoplasm Malignant Primary Clinical Trial
Verified date | January 2018 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Total mastectomy - Modified radical mastectomy - Nipple-sparing mastectomy - American Society of Anesthesiologists physical status I or II - Postoperative use of intravenous patient-controlled analgesia Exclusion Criteria: - Chronic analgesia medication - Pregnancy - Lactating women - Previous operation history due to breast cancer - Cooperation with other surgery - Contraindication of nefopam |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device | At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month | ||
Secondary | Change of numerical rating scale for postoperative pain | At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month |
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