Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Maxigesic
* Drug: 0.9% saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: 0.9% saline solution/ Study group: Maxigesic
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Study group<br>Group administered Maxigesic solution | Drug: Maxigesic<br>* 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.<br>|
| Experimental: Control group<br>Group administerd 0.9% saline solution | Drug: 0.9% saline solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse reactions (Safety) | Adverse reactions related to NSAIDs: headache, dizziness, nausea, vomiting, itching, drowsiness, abdominal pain, constipation, gastrointestinal bleeding, hypotension. | postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours |