Effectiveness of Nefopam in Breast Cancer Surgery
Not Applicable
- Conditions
- Breast Neoplasm Malignant Primary
- Interventions
- Drug: Normal Saline
- Registration Number
- NCT02949310
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 88
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Normal Saline Placebo use instead of nefopam Nefopam Nefopam Intraoperative use of nefopam 40 mg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change of numerical rating scale for postoperative pain At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of