NCT07368413

Comparison of the Analgesic Efficacy of Erector Spinae Plane Block in Breast-Conserving Surgery Versus Serratus Anterior Block Combined With Additional Pecto-Intercostal II Block

Comparison of Analgesic Efficacy and Opioid Consumption of Erector Spinae Plane Block Versus Serratus Anterior Block With Additional Pecto-Intercostal II Block in Breast-Conserving Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Kayseri City Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized study will compare the effects of Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block combined with Pectoral Nerve Block Type II (SAPB + PECS II) on intraoperative analgesia and postoperative opioid consumption in patients undergoing breast cancer surgery. Seventy patients (ASA I-III, aged 18-75 years) will be randomized into two groups using the sealed envelope method. Ultrasound-guided blocks will be performed preoperatively by the same anesthesiologist, with Group 1 receiving ESPB and Group 2 receiving a combined SAPB + PECS II technique performed through a single skin puncture (single needle entry site) with sequential injections into the two target fascial planes. All patients will undergo surgery under general anesthesia and receive postoperative analgesia via morphine patient-controlled analgesia. Pain scores and total opioid consumption will be statistically analyzed, with p \< 0.05 considered significant.

Detailed description

Study Design and Methods The study planned to compare the effects of Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block combined with Pectoral Nerve Block Type II (SAPB + PECS II) on intraoperative analgesia and postoperative opioid requirement in patients undergoing breast cancer surgery will be conducted at Kayseri City Hospital with voluntary participants. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Anesthesia and Block Procedures All patients will undergo surgery under general anesthesia. To provide intraoperative and postoperative analgesia, block procedures will be performed in the preoperative period before induction of general anesthesia by the same experienced anesthesiologist. The effectiveness of the blocks will be evaluated using the pinprick test following the procedure. Group 1: ESPB Technique Standard preoperative monitoring, including ECG, SpO₂, and non-invasive blood pressure (NIBP), will be applied under operating room conditions. Patients will be positioned in the lateral decubitus position with the operative side facing upward. A PHILIPS ClearVue 550 ultrasound device with a high-resolution linear probe (12-5 MHz) will be used. The probe and cable will be covered with a sterile sheath, sterile ultrasound gel will be applied, and skin antisepsis will be achieved using povidone-iodine. The transverse process beneath the erector spinae muscle will be targeted. A 22G atraumatic, nerve stimulator-equipped block needle (B. Braun Stimuplex® Ultra 360, 0.7 × 80 mm) will be advanced in-plane from lateral to medial. After confirmation of correct placement by saline hydrodissection, 35 mL of 0.25% bupivacaine will be injected slowly, and longitudinal spread will be observed. Block success will be assessed using the pinprick test. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Group 2: SAPB + PECS II Technique Standard monitoring will be applied. Patients will be placed in the supine position with the ipsilateral arm abducted. Using the same ultrasound equipment, the PECS II block will be performed first. The needle will be advanced in-plane into the fascial plane between the pectoralis minor and serratus anterior muscles, and 15 mL of 0.25% bupivacaine will be injected after hydrodissection. Both blocks will be performed through a single skin puncture (single needle entry site); after the first injection, the needle will be redirected under ultrasound guidance to the serratus anterior plane for the subsequent injection. Subsequently, the SAPB will be performed at the level of the 5th or 6th rib, with the needle tip positioned beneath the serratus anterior muscle. After confirming the correct fascial plane, 20 mL of 0.25% bupivacaine will be injected. Block efficacy will be assessed using the pinprick test. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Intraoperative and Postoperative Management After induction with propofol (2-3 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg), anesthesia will be maintained with sevoflurane at 1 MAC and remifentanil infusion (0.05-0.25 µg/kg/min), adjusted according to hemodynamic parameters. All patients will receive 1 g paracetamol and ondansetron 0.15 mg/kg IV intraoperatively. Postoperatively, patients will be followed in the PACU for 30 minutes and connected to a morphine patient-controlled analgesia (PCA) device. Rescue analgesia and antiemetic protocols will be applied according to NRS and nausea-vomiting scale scores. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ PCA Preparation The PCA solution will be prepared with 100 mg morphine diluted in 100 mL saline (1 mg/mL), without basal infusion. The lockout interval will be 15 minutes, and the maximum dose will be 4 mg per hour. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Data Analysis After completion of patient enrollment, collected data will be statistically analyzed and recorded.

Conditions

• Pain Management in Breast Surgery
• Pain After Surgery
• Regional Anaesthesia

Interventions

Type	Name	Description
PROCEDURE	SAPB + PECS II Technique	Investigators will perform both blocks with a single injection.
PROCEDURE	Erector Spinae Plane Block	Investigators will perform the block before the patient receives general anesthesia and investigators will check it with the pinprick test.

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-07-01
• Completion: 2026-07-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Turkey (Türkiye)