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

Comparison of Axillary Leakage Between Superficial and Deep Serratus Anterior Plane Blocks in Breast Cancer Surgery: A Double-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1011260005
Enrollment
88
Registered
2026-04-23
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms Breast Cancer, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection, Postoperative Pain

Interventions

[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 t
Nerve Block, Regional Anesthesia, Serratus Anterior Plane Block, Levobupivacaine

Sponsors

Sawada Atsushi
Lead Sponsor

Eligibility

Sex/Gender
Female

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

MeasureTime frame
Leakage Score (LS) assessed by the operating surgeon at completion of sentinel lymph node biopsy

Secondary

MeasureTime 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

Public ContactAtsushi Sawada

Sapporo Medical University School of Medicine

atusihon7@gmail.com+81-11-688-9663

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026