Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

NCT06174363 | Recruiting DMC

• 1 other identifier: 4-2022-1650
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Analgesic effect of Maxigesic

  Postoperative pain intensity is assessed with NRS: numerical rating scales (0 = no pain ∼ 10 = worst pain).

  postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours

Secondary Outcomes (1)

• Incidence of Adverse reactions (Safety)

  postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours

Study Arms (2)

Study group

PLACEBO COMPARATOR

Group administered Maxigesic solution

Drug: Maxigesic

Control group

EXPERIMENTAL

Group administerd 0.9% saline solution

Drug: 0.9% saline solution

Interventions

Maxigesic 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.

Study group

0.9% saline solution 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.

Control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)

You may not qualify if:

• ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jin Sun Cho

CONTACT

82-2-2228-2419; chjs0214@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Model Details: Control group: 0.9% saline solution/ Study group: Maxigesic

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 28, 2023
• Primary Completion: December 26, 2025
• Study Completion: December 26, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

KR (1)