About this trial
Postoperative pain following modified radical mastectomy remains a significant clinical challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited.
This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 to 65 years.
Scheduled for elective modified radical mastectomy under general anesthesia.
American Society of Anesthesiologists (ASA) physical status I-III.
Body mass index (BMI) <35 kg/m².
Disqualifiers
Known allergy or hypersensitivity to local anesthetics.
Coagulation disorders or bleeding diathesis.
Infection or inflammation at the planned block site.
ASA physical status IV or higher.
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
Procedure/SurgeryAn ultrasound-guided serratus posterior superior intercostal plane block will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles.
Ultrasound-Guided Serratus Anterior Plane Block (SAPB)
Procedure/SurgeryUltrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain intensity
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.
Secondary outcomes
Intraoperative remifentanil consumption
Total intraoperative remifentanil consumption will be recorded in micrograms.
Postoperative tramadol consumption
Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.
Postoperative nausea and vomiting
Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.
Quality of recovery
Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.
Locations
Sponsors and contacts
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