NCT06174363

Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

Analgesic Efficacy of Maxigesic Added to Opioid Based-PCA in Patients Undergoing Breast Cancer Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Maxigesic	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.
DRUG	0.9% saline solution	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.

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-12-26
• Completion: 2025-12-26
• First posted: 2023-12-18
• Last updated: 2025-07-20

Locations

1 site across 1 country: South Korea