Timing of Serratus Anterior Plane Block in Mastectomy Surgery

NCT07661212 | Not Yet Recruiting

• 1 other identifier: 2026/240
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Recovery After Mastectomy; Serratus Anterior Plane Block; Postoperative Pain; Mastectomy

Keywords

Serratus Anterior Plane Block; Postoperative Pain; Mastectomy; Regional Anesthesia; Pain Management; Bupivacaine; Quality of Recovery; CRP; Neutrophil-Lymphocyte Ratio; Inflammation; Breast Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Quality of Recovery at 24 Hours

  Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery.

  24 hours after surgery

Secondary Outcomes (14)

• Resting Postoperative Pain Scores

  Postoperative 0 to 24 hours

• Intraoperative Remifentanil Consumption

  During surgery

• Postoperative Opioid Consumption

  Postoperative 0 to 24 hours

• Postoperative Non-Opioid Analgesic Consumption

  Postoperative 0 to 24 hours

• Time to First Analgesic Requirement

  Postoperative 0 to 24 hours

Study Arms (2)

Preincisional SAP Block

EXPERIMENTAL

Participants 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.

Procedure: Ultrasound-Guided Serratus Anterior Plane Block; Drug: Bupivacaine

End-of-Surgery SAP Block

EXPERIMENTAL

Participants 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.

Procedure: Ultrasound-Guided Serratus Anterior Plane Block; Drug: Bupivacaine

Interventions

Ultrasound-Guided Serratus Anterior Plane Block PROCEDURE

Ultrasound-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.

Also known as: SAP Block

End-of-Surgery SAP Block; Preincisional SAP Block

Bupivacaine DRUG

Bupivacaine 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.

End-of-Surgery SAP Block; Preincisional SAP Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 years or older
• Scheduled for elective unilateral mastectomy surgery
• Planned to undergo surgery under general anesthesia
• American Society of Anesthesiologists physical status I-III
• Willing and able to participate in the study
• Provision of written informed consent

You may not qualify if:

• Refusal to participate in the study
• Known allergy to local anesthetics planned for use in the study
• Chronic opioid use
• Current steroid or immunosuppressive therapy
• Presence of chronic inflammatory disease
• Surgical duration shorter than 30 minutes
• Active infection
• Coagulopathy
• Infection at the planned block site
• Pregnancy or lactation
• Advanced hepatic failure or advanced renal failure
• Reoperation due to recurrent disease
• Inability to communicate adequately or to provide reliable pain scores
• Psychiatric or neurological condition limiting reliable completion of the QoR-15 questionnaire or Numeric Rating Scale assessments

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (3)

• Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1.

  PMID: 37655864 BACKGROUND

• Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.

  PMID: 31021882 BACKGROUND

• Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.

  PMID: 33209056 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Inflammation

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fatma Çiğdem ÖZAKIN, MD

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Çiğdem ÖZAKIN, MD

CONTACT

+905464168250; f.cigdemulus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

TU (1)