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

NCT07368413 | Recruiting

• 1 other identifier: KayseriCH-AR-ERC-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

breast surgery; pain; Regional Anaesthesia; Serratus Anterior Plane Block; Pectoral Nerve Block Type 2; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• the Numerical Rating Scale

  The Numerical Rating Scale is a subjective pain assessment tool in which patients rate their pain intensity on a scale from 0 to 10, where 0 indicates no pain (the best/most favorable score) and 10 represents the worst pain imaginable (the worst/least favorable score)

  24 hours or until the patient is discharged

Secondary Outcomes (2)

• Nausea and Vomiting Scale

  24 hours or until the patient is discharged

• Apfel Risk Score

  24 hours or until the patient is discharged

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block

SAPB + PECS II Technique

ACTIVE COMPARATOR

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 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); without withdrawing the needle from the skin, it will be redirected under ultrasound guidance to access the second target fascial plane. Subsequently, the SAPB will be performed by advancing the probe to the 5th or 6th rib level. The needle will be placed beneath the serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be injected following confirmation of the correct fascial plane. Block efficacy will again be assessed using the pinprick test.

Procedure: SAPB + PECS II Technique

Interventions

SAPB + PECS II Technique PROCEDURE

Investigators will perform both blocks with a single injection.

Also known as: group 2

SAPB + PECS II Technique

Erector Spinae Plane Block PROCEDURE

Investigators will perform the block before the patient receives general anesthesia and investigators will check it with the pinprick test.

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: only biological females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• ASA physical status I-III
• No history of bleeding or coagulation disorders
• Absence of neuropathy
• Preoperative breast region NRS score \< 4

You may not qualify if:

• systemic or regional infection
• known allergy to local anesthetics
• Unwillingness to participate in the study

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kasyeri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Saposins

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphingolipid Activator Proteins; Coenzymes; Enzymes and Coenzymes

Study Officials

• Çiğdem Ünal Kantekin, Associate Professor of Medicin

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdoğan Rahmi Çinçin, Resident Doctor

CONTACT

+90538 862 31 08; erdo.cincin@gmail.com

Çiğdem Ünal Kantekin, Associate Professor of Medicin

CONTACT

+905054433056; drcgdm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The person who creates the block and the person who looks at the patients' pain scores are different.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant Doctor

Model Details: two groups without a control group

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 26, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)