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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Placebo Comparator | Group administered Maxigesic solution |
|
| Control group | Experimental | Group administerd 0.9% saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Sun Cho | Contact | 82-2-2228-2419 | chjs0214@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
Data obtained through this study may be provided to qualified researchers with an academic interest in perioperative analgesia in cancer surgery. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Control group: 0.9% saline solution/ Study group: Maxigesic
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|
| 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. |
|
| D017437 |
| Skin and Connective Tissue Diseases |