Timing of Serratus Anterior Plane Block in Mastectomy Surgery
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study ID
- NCT07661212
- Status
- Not Yet Recruiting
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Conditions
- Mastectomy
- Postoperative Pain
- Quality of Recovery After Mastectomy
- Serratus Anterior Plane Block
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ultrasound-Guided Serratus Anterior Plane Block — PROCEDUREUltrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation.
- Bupivacaine — DRUGBupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation.
Study Details
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined. This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine. The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables. The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.
Key Dates
- First listed
- Jun 22, 2026
- Start date
- Sep 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Sep 1, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Preincisional SAP BlockParticipants assigned to this arm will receive ultrasound-guided serratus anterior plane block after induction of general anesthesia and before surgical incision. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management.
- Experimental: End-of-Surgery SAP BlockParticipants assigned to this arm will receive ultrasound-guided serratus anterior plane block after completion of surgery and before extubation. The block will be performed on the operative side using 25 mL of 0.25% bupivacaine, in addition to standardized general anesthesia and postoperative analgesic management.
Primary Outcome Measure
Postoperative Quality of Recovery at 24 Hours [ Time Frame: 24 hours after surgery ]
Central Contacts
- Fatma Çiğdem ÖZAKIN, MD+905464168250
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