None listed
Conditions
Interventions
Drug : The inclusion and exclusion criteria, if you are selected as a suitable participant for this clinical trial, you will be randomly assigned to either the experimental group or the active compara
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.participant scheduled for breast reconstruction with deep inferior epigastric perforator flap. 2.participant aged 20years or older and under 65. 3.participant classified as physical status I-III according to the American Society of Anesthesiologists (ASA) classification.
Exclusion criteria
Exclusion criteria: 1. Allergic reactions or clinically significant hypersensitivity to drugs such as acetaminophen, ibuprofen, aspirin, opioid analgesics, or any non - steroidal anti - inflammatory drugs ( NSAIDs ) 2. Chronic pain requiring long - term use of opioid analgesics 3. Other severe pain unrelated to the target disease, which could confuse the pain assessment during the screening process 4. History of previous non - minor surgeries related to cancer diagnosis ( Minor surgeries include : appendectomy, chalecystectomy. hernia surgery. etc. ) 5. Liver dysfunction : Elevated AST. ALT levels (> 40 IU / L ) n pre - surgery tests, severe liver disease, liver cirrhosis, or a history of these conditions 6. Renal dysfunction : Estimated glomerular filtration rate ( eGFR ) N 60 ml / min as calculated by the CKD - EPI formula based on pre - surgery blood tests, chronic kidney disease ( CKD ), or end - stage renal disease ( Cr > 1.6 mg / dL ) 7. Use of certain medications : Patients taking barbiturates or tricyclic antidepressants 8. Non - consent : Patients who do not consent to participate In the study 9. Judgment by the investigator or research staff that the patient is not appropriate for inclusion in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain changes before surgery, on the day of surgery, and during the 4 days post-surgery. The difference between the maximum pain score over 4 days and the pain score on the day of surgery. The maximum pain score refers to the highest value recorded on the NRS pain scale. Numeric Pain Rating Scale (NRS): (0 = no pain, 10 = worst possible pain) | — |
Secondary
| Measure | Time frame |
|---|---|
| Total amount of opioid analgesics administered as rescue medication within 72 hours after surgery.Total amount of intravenous fentanyl used within 3 days after surgery,Incidence of complications such as postoperative nausea and vomiting (PONV) starting from day 2 after surgery,Time of first opioid analgesic rescue medication use within 72 hours after surgery ,Frequency of patient's additional analgesic requests within 4 days after surgery,lab test results on the 3rd day after surgery: AST/ALT, BUN/Creatinine;Adverse reactions during the 4 days after surgery(nausea, vomiting, itching, drowsiness, constipation, diaphoresis, loss of appetite, facial flushing, injection site pain) | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Supp Um
Asan Medical Center
Outcome results
None listed