Analgesic Efficacy of Maxigesic in Breast Cancer Surgery
- Conditions
- Breast Cancer
- Interventions
- Drug: 0.9% saline solution
- Registration Number
- NCT06174363
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 84
- Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)
- ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Maxigesic Group administered Maxigesic solution Control group 0.9% saline solution Group administerd 0.9% saline solution
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of