Breast Neoplasms Breast Cancer, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Postoperative Pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who provided written informed consent to participate in this study Female patients aged 20 to 79 years at the time of surgery Patients with an American Society of Anesthesiologists physical status (ASA-PS) of I or II
Exclusion criteria
Exclusion criteria: Patients with a known allergy to local anesthetics, general anesthetics, opioids, or acetaminophen Patients with signs of infection at the puncture site Patients with chronic pain for more than 3 months and preoperative opioid use Patients receiving systemic steroid therapy for more than 3 months (excluding inhaled or topical steroids) Patients with psychiatric disorders or cognitive impairment that precludes accurate postoperative pain assessment Patients with a body weight less than 40 kg or a body mass index (BMI) more than 35 kg/m^2 Patients scheduled for simultaneous bilateral surgery Patients with a history of surgery (excluding biopsy performed for diagnostic purposes) or radiation therapy on the ipsilateral breast Pregnant patients Any other patients deemed unsuitable for participation by the principal investigator or attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leakage Score (LS) assessed by the operating surgeon at completion of sentinel lymph node biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| LS at the end of axillary lymph node dissection Postoperative pain scores evaluated using a Numerical Rating Scale (NRS, 0-10) upon return to the ward, and at 2, 6, 12, and 24 hours postoperatively Quality of postoperative recovery at 24 hours postoperatively, assessed using the Japanese version of the Quality of Recovery-15 (QoR-15J) questionnaire Frequency and total consumption of rescue analgesics intraoperatively and up to 24 hours postoperatively Time to the first postoperative rescue analgesic requirement Incidence of postoperative nausea and vomiting (PONV) Incidence of complications (e.g., pneumothorax, hematoma, local anesthetic systemic toxicity) Degree of surgical field interference associated with sentinel lymph node biopsy (and axillary lymph node dissection) (interference score) Time from initiation to completion of sentinel lymph node biopsy Time from initiation to completion of axillary lymph node dissection in cases converted to axillary lymph node dissection | — |
Contacts
Sapporo Medical University School of Medicine