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JAPANESE
JRCT ID: jRCT1011260005

Registered date:23/04/2026

A Study Comparing the Effects of Two Types of Serratus Anterior Plane Blocks (Nerve Blocks) on Axillary Lymph Node Surgery in Breast Cancer

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedBreast Neoplasms
Date of first enrollment23/04/2026
Target sample size88
Countries of recruitment
Study typeInterventional
Intervention(s)[Intervention 1 (Group S, Superficial block group)] After the induction of general anesthesia, an ultrasound-guided superficial serratus anterior plane block (an approach targeting the plane between the latissimus dorsi and serratus anterior muscles) will be performed, and 20 mL of 0.25% levobupivacaine will be injected. [Intervention 2 (Group D, Deep block group)] After the induction of general anesthesia, an ultrasound-guided deep serratus anterior plane block (an approach targeting the plane between the serratus anterior and intercostal muscles) will be performed, and 20 mL of 0.25% levobupivacaine will be injected.

Outcome(s)

Primary OutcomeLeakage Score (LS) assessed by the operating surgeon at completion of sentinel lymph node biopsy
Secondary OutcomeLS 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderFemale
Include criteriaPatients 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
Exclude criteriaPatients 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

Related Information

Contact

Public contact
Name Atsushi Sawada
Address S1-W16, Chuo-Ku, Sapporo, Hokkaido, Japan Hokkaido Japan 060-8543
Telephone +81-11-688-9663
E-mail atusihon7@gmail.com
Affiliation Sapporo Medical University School of Medicine
Scientific contact
Name Atsushi Sawada
Address S1-W16, Chuo-Ku, Sapporo, Hokkaido, Japan Hokkaido Japan 060-8543
Telephone +81-11-688-9663
E-mail atusihon7@gmail.com
Affiliation Sapporo Medical University School of Medicine