About this trial
This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency.
In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients.
The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged between 18 and 75 years
Patients scheduled for elective mastectomy surgery
American Society of Anesthesiologists (ASA) physical status I-III
Patients who provide written informed consent
Disqualifiers
Patients who refuse to participate in the study
Patients with American Society of Anesthesiologists (ASA) physical status IV or V
Patients receiving anticoagulant therapy or with suspected coagulopathy
Patients with known allergy to local anesthetic agents
Trial design
Parallel
Treatments tested in this trial
SAP Block
Procedure/SurgeryUnder ultrasound guidance with a linear probe, the needle is inserted along the posterior axillary line between the second and seventh ribs and advanced into the plane between the serratus anterior muscle and the rib surface. A total of 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is injected.
SPSIP Block
Procedure/SurgeryUnder ultrasound guidance with a linear probe, the superomedial border of the scapula on the operative side is identified. The needle is inserted medial to the scapula between the second and seventh ribs and advanced into the interfascial plane between the serratus posterior superior muscle and the intercostal muscles. Subsequently, 30 mL of 0.25% bupivacaine (maximum dose 2 mg/kg/day) is administered.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Pain Intensity
Postoperative pain intensity and time to first analgesic requirement will be evaluated. Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at 0 and 30 minutes, and at 1, 2, 4, 8, 12, 24, 36, and 48 hours postoperatively, both at rest and during movement, by a blinded investigator
Secondary outcomes
Total Analgesic Consumption
Total consumption of additional analgesics (paracetamol and opioid) will be recorded.
Additional Analgesic Requirement
The number of patients requiring additional analgesia and the frequency of administration will be recorded.
Intraoperative Opioid Consumption
The total amount of opioids administered intraoperatively will be recorded.
Intraoperative mean arterial pressure (mmHg)
Mean arterial pressure (mmHg) will be recorded at 30 minute intervals during surgery and summarized as mean values.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.