Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

NCT ID: NCT06174363

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-28
• Study Completion Date: 2025-12-26

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Study group

Group administered Maxigesic solution

Group Type: PLACEBO_COMPARATOR

Maxigesic

Intervention Type: DRUG

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.

Control group

Group administerd 0.9% saline solution

Group Type: EXPERIMENTAL

0.9% saline solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Jin Sun Cho

M.D, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin Sun Cho

Role: CONTACT

chjs0214@yuhs.ac

82-2-2228-2419

Facility Contacts

Jin Sun Cho

Role: primary

Other Identifiers

4-2022-1650

Identifier Type: -

Identifier Source: org_study_id