RecruitingNot ApplicableNCT06174363

Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

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

Sponsor

Yonsei University

Enrollment

84 participants

Start Date

Dec 28, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a pain medication called Maxigesic (a combination of paracetamol and ibuprofen) effectively reduces pain after breast cancer surgery, as part of efforts to find better, opioid-sparing pain management strategies for patients recovering from surgery. **You may be eligible if...** - You are an adult scheduled for breast cancer surgery - You do not have contraindications to taking either paracetamol (acetaminophen) or ibuprofen - You are able to give informed consent **You may NOT be eligible if...** - You have a known allergy or intolerance to paracetamol (acetaminophen) or ibuprofen (or other NSAIDs) - You have severe kidney, liver, or gastrointestinal conditions that make these medications unsafe - You have significant cardiovascular disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DRUG0.9% 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.

Locations(1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

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