Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy

Официальное название

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial

Обзор

Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine. Regional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief. The purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting. This study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.

Подробное описание

Breast cancer represents a major global health burden and remains one of the leading causes of cancer-related mortality among women. Modified radical mastectomy (MRM) is frequently performed as part of surgical management. Despite advances in perioperative care, postoperative pain following MRM remains significant due to extensive tissue dissection involving skin, muscles, and intercostal nerves.

Inadequate postoperative analgesia may result in delayed mobilization, increased opioid consumption, higher incidence of opioid-related adverse effects, prolonged hospital stay, and potential development of chronic post-mastectomy pain syndrome.

Ultrasound-guided fascial plane blocks have gained popularity as part of multimodal analgesia strategies in breast surgery. The erector spinae plane block (ESPB) involves injection of local anesthetic deep to the erector spinae muscle at the thoracic level, allowing spread to dorsal and ventral rami of spinal nerves. ESPB has demonstrated effectiveness in reducing postoperative pain scores and opioid consumption after breast surgery.

The serratus posterior superior intercostal plane (SPSIP) block is a recently described regional anesthesia technique. It involves ultrasound-guided injection of local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles, targeting the intercostal nerves. Preliminary reports suggest that SPSIP may provide effective thoracic analgesia with a favorable safety profile.

This prospective randomized clinical trial will include 50 female breast cancer patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Patients will be randomly assigned into two equal groups:

Group SPSIP: Ultrasound-guided serratus posterior superior intercostal plane block.

Group ESPB: Ultrasound-guided erector spinae plane block.

Both blocks will be performed preoperatively under ultrasound guidance using 20 mL of 0.25% bupivacaine. All patients will receive standardized general anesthesia and multimodal analgesia.

The primary outcome measure is total morphine consumption during the first 24 hours postoperatively.

Secondary outcomes include:

Visual Analog Scale (VAS) pain scores at rest and during movement at predefined time intervals (1, 3, 6, 12, 18, and 24 hours)

Time to first request for rescue analgesia

Hemodynamic parameters intraoperatively and postoperatively

Recovery time

Patient satisfaction

Incidence of adverse effects such as nausea and vomiting

The study hypothesis is that SPSIP block provides postoperative analgesia comparable or superior to ESPB in patients undergoing modified radical mastectomy.

The results of this study may contribute to optimizing regional anesthesia strategies for breast cancer surgery and support evidence-based, opioid-sparing perioperative pain management.

Вмешательства

• Процедура Serratus Posterior Superior Intercostal Plane Block
  Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery.
• Процедура Erector Spinae Plane Block
  Ultrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery.

Первичные конечные точки

• Total 24-Hour Postoperative Morphine Consumption [Срок оценки: First 24 hours postoperatively]

Критерии участия

Критерии включения

Female patients diagnosed with breast cancer

Scheduled for modified radical mastectomy (MRM)

American Society of Anesthesiologists (ASA) physical status II or III

Age 18-65 years

Body mass index (BMI) > 20 kg/m² and < 35 kg/m²

Ability to understand the study protocol and provide written informed consent

Критерии исключения

Patient refusal to participate

ASA physical status IV or higher

BMI ≤ 20 kg/m² or ≥ 35 kg/m²

Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications

History of chronic pain or regular opioid use

Significant psychiatric disorders affecting pain assessment

Contraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy)

Severe respiratory, cardiac, hepatic, or renal disease

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

Египет · 1 центр

• National Cancer Institute - Cairo University — Cairo

Публикации

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb. PMID 36883093
• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593

Идентификаторы

NCT: NCT07446868 · SPSIP-ESPB-MRM-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗