Effectiveness of Nefopam in Breast Cancer Surgery

Breast Neoplasm Malignant Primary Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02949310
• Other study ID #: Nefo-TM & MRM
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Primary
• Breast Neoplasms
• Neoplasms

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