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) studied | Breast Neoplasms |
| Date of first enrollment | 23/04/2026 |
| Target sample size | 88 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | Leakage Score (LS) assessed by the operating surgeon at completion of sentinel lymph node biopsy |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | < 80age old |
| Gender | Female |
| Include 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 |
| Exclude 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 |
Related Information
| Primary Sponsor | Sawada Atsushi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Atsushi Sawada |
| Address | S1-W16, Chuo-Ku, Sapporo, Hokkaido, Japan Hokkaido Japan 060-8543 |
| Telephone | +81-11-688-9663 |
| 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 |
| atusihon7@gmail.com | |
| Affiliation | Sapporo Medical University School of Medicine |