Breast Cancer
Conditions
Brief summary
The present study aims to find a perioperative analgesic method that provides sufficient analgesia while reducing immune compromise in cancer surgery. This study is to investigate the analgesic effect and safety of Maxigesic inj. (a combination of acetaminophen 1000 mg and ibuprofen 300 mg), which is added to opioid-based IV-PCA in patients undergoing breast cancer surgery.
Interventions
DRUGMaxigesic
For postoperative analgesia, 50 mcg of fentanyl was administered 15 minutes before the end of surgery, and IV-PCA (fentanyl 1.0 mcg/kg, ramosetron 0.3 mg, total 250cc, infusion rate 5cc/h, bolus 0.5 cc, lock-out time 15min) is started. Additionally, in the Maxigesic group, one vial of Maxigesic (acetaminophen 1000mg/ ibuprofen 300mg) is administered 15 minutes before the end of the surgery, and 2 vials of Maxigesic are added to the IV-PCA.
For postoperative analgesia, 50 mcg of fentanyl was administered 15 minutes before the end of surgery, and IV-PCA (fentanyl 1.0 mcg/kg, ramosetron 0.3 mg, total 250cc, infusion rate 5cc/h, bolus 0.5 cc, lock-out time 15min) is started. Additionally, in the control group, the same amount of 0.9% saline solution with Maxigesic is administered.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Control group: 0.9% saline solution/ Study group: Maxigesic
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)
Exclusion criteria
* ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic effect of Maxigesic | postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours | Postoperative pain intensity is assessed with NRS: numerical rating scales (0 = no pain ∼ 10 = worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse reactions (Safety) | postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours | Adverse reactions related to NSAIDs: headache, dizziness, nausea, vomiting, itching, drowsiness, abdominal pain, constipation, gastrointestinal bleeding, hypotension. |
Countries
South Korea
Contacts
Primary ContactJin Sun Cho
Outcome results
None listed