Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

Yonsei University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: Maxigesic; Drug: 0.9% saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06174363

4-2022-1650

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Study group

Placebo Comparator group

Description:

Group administered Maxigesic solution

Treatment:

Drug: Maxigesic

Control group

Experimental group

Description:

Group administerd 0.9% saline solution

Treatment:

Drug: 0.9% saline solution