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Search / Trial NCT06575049

Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Aug 26, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different medications, MAXIGESIC IV and Ketorolac, to see which one results in fewer complications after breast cancer surgery. The main complications being looked at are seromas (which are fluid collections) and hematomas (which are blood clots). Researchers believe that MAXIGESIC, which contains a higher dose of ibuprofen, might help reduce these complications compared to Ketorolac.

To participate in this trial, women aged 18 and older who are having certain types of breast surgery, such as total mastectomy or breast-conserving surgery, may be eligible. Participants must be in good overall health and have normal kidney and liver function. They will need to agree to take part in the study by signing a consent form. The trial is currently not recruiting participants, but it aims to help improve post-surgery care for breast cancer patients by finding the safest and most effective pain relief options.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Systemic performance status 0-2 according to ECOG criteria
  • Patients with adequate renal function: serum Cr 1.4 mg/dL or less
  • Patients with adequate liver function Bilirubin, AST/ALT: 1.5 times or less of the upper limit of normal, Alkaline phosphatase: 1.8 times or less of the upper limit of normal
  • Patients undergoing total mastectomy with SLNB or ALND (mastectomy and axillary sentinel lymph node dissection)
  • Patients undergoing breast-conserving surgery with ALND (mastectomy and axillary dissection)
  • Patients who voluntarily decided to participate in this study and signed a written informed consent form
  • Exclusion Criteria:
  • Patients undergoing immediate reconstruction operation
  • Patients with drug allergies to painkillers and anti-inflammatory drugs
  • Patients with a physical condition that would interfere with understanding and submitting the consent form

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported