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

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

NCT ID: NCT06575049

Condition: Breast Cancer
Post-Operative Hematoma
Seroma as Procedural Complication
Post-Op Complication

Conditions: Official terms:
Breast Neoplasms
Hematoma
Seroma
Postoperative Complications

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Summary: The investigators aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. The investigators seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.

Criteria for eligibility:

Study pop:
Among patients who underwent breast cancer surgery at Seoul National University Hospital from January 1, 2023 to December 31, 2023, 127 patients were prescribed ketorolac and wore compression dressings. The number of patients was calculated to be approximately 60 to collect basic data to confirm the feasibility of conducting the main study.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 20 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: May 1, 2025

Completion date: February 20, 2026

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06575049