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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02949310
Other study ID # Nefo-TM & MRM
Secondary ID
Status Recruiting
Phase N/A
First received October 26, 2016
Last updated January 9, 2018
Start date October 2016
Est. completion date December 2018

Study information

Verified date January 2018
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nefopam

Normal Saline


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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