Breast Neoplasm Malignant Primary
Conditions
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.
Interventions
DRUGNefopam
DRUGNormal Saline
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change of numerical rating scale for postoperative pain | At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month |
Countries
South Korea
Outcome results
None listed