Breast cancer Postmastectomy pain Breast cancer Mastectomy Nefopam Postmastectomy pain
Conditions
Interventions
Participants undergoing mastectomy will receive an intravenous nefopam 20 mg added to 0.9% NaCl solution 100 mL preincision,
intraoperatively. After surgery,
participants will receive an intravenous nefopam 60 mg added to 0.9%NaCl solution 250 mL drip in 24 hour.,Participants undergoing mastectomy will receive an intravenous 0.9%NaCl solution 100 mL preinc
participants will receive an intravenous 0.9%NaCl solution 250 mL drip in 24 hour.
Experimental Drug,Placebo Comparator Drug
Sponsors
Ratchadapisek Sompoch Endowment Fund, Chulalongkorn University
Eligibility
Sex/Gender
Female
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with breast cancer 2. Undergoing unilateral simple mastectomy, modified radical mastectomy, radical mastectomy, skin sparing mastectomy, nipple sparing mastectomy with or without axillary lymphnode dissection 3. ASA physical status I-III
Exclusion criteria
Exclusion criteria: 1. Patient refusal 2. Unable to properly use intravenous PCA machine 3. Preexisting chronic pain 4. Currently take analgesic medications within 14 days 5. Currently take monoamine oxidase inhibitor within 14 days 6. Pregnant or lactation 7. Previous surgery (excision or mastectomy) due to breast cancer 8. Medical history of seizure, acute angle-closure glaucoma, myocardial infarction, chronic obstructive pulmonary disease 9. Renal impairment (eGFR lower than 30 mL/min/1.73sq.m.) 10. Acute liver failure or severe liver impairment 11. Contraindicated to any medication using in study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine consumption at 24 hours after surgery collected data from PCA machine in milligram of morphine | — |
Secondary
| Measure | Time frame |
|---|---|
| Total morphine consumption At post anesthesia care unit, at 6 and 48 hours after surgery collected data from PCA machine in milligram of morphine,Severity of pain At post anesthesia care unit, at 6, 24, and 48 hours after surgery Patient reported as verbal numerical rating scale 0-10,Incidence of chronic post operative pain At 3 months after surgery Patient reported during telephone follow up,Incidence of neuropathic pain At 48 hours and 3 months after surgery Patient reported outcome using Thai DN4 questionaire,Adverse events within 48 hours after surgery Patient reported or observed by health care personnels | — |
Countries
Thailand
Contacts
Public ContactSuppanich Mahachairithiporn
King Chulalongkorn Memorial Hospital
Outcome results
None listed