Timing of Serratus Anterior Plane Block in Mastectomy Surgery

Официальное название

The Effect of Serratus Anterior Plane Block Timing on Postoperative Quality of Recovery, Postoperative Pain, and Inflammatory Response in Elective Unilateral Mastectomy Surgery: A Prospective Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Процедура Ultrasound-Guided Serratus Anterior Plane Block
  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
• Препарат Bupivacaine
  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.

Первичные конечные точки

• Postoperative Quality of Recovery at 24 Hours [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (12)

• Resting Postoperative Pain Scores [Срок оценки: Postoperative 0 to 24 hours]
• Intraoperative Remifentanil Consumption [Срок оценки: During surgery]
• Postoperative Opioid Consumption [Срок оценки: Postoperative 0 to 24 hours]
• Postoperative Non-Opioid Analgesic Consumption [Срок оценки: Postoperative 0 to 24 hours]
• Time to First Analgesic Requirement [Срок оценки: Postoperative 0 to 24 hours]
• Postoperative Nausea and Vomiting [Срок оценки: Postoperative 0 to 24 hours]
• Length of Hospital Stay [Срок оценки: From surgery until hospital discharge, assessed up to 30 days.]
• C-Reactive Protein Level [Срок оценки: Postoperative 6 hours]
• White Blood Cell Count [Срок оценки: Postoperative 6 hours]
• Absolute Neutrophil Count [Срок оценки: Postoperative 6 hours]
• Absolute Lymphocyte Count [Срок оценки: Postoperative 6 hours]
• Neutrophil-to-Lymphocyte Ratio [Срок оценки: Postoperative 6 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bakırköy Dr. Sadi Konuk Training and Research Hospital — Istanbul

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07661212 · 2026/240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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