Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy

Официальное название

Comparison of Continuous Erector Spinae Plane Block With Ropivacaine Versus No Block on Postoperative Pain, NF-κB Levels, Opioid Consumption, and Quality of Recovery in Patients Undergoing Elective Mastectomy

Обзор

This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.

Подробное описание

Breast cancer is one of the most common malignancies worldwide and frequently requires surgical management in the form of mastectomy. Postoperative pain following mastectomy remains a significant clinical problem, with a substantial proportion of patients experiencing moderate to severe pain. Inadequate pain control is associated with increased opioid consumption, delayed recovery, and a higher risk of developing chronic pain.

The inflammatory response plays an important role in postoperative pain, particularly through the activation of nuclear factor kappa B (NF-κB), a key transcription factor that regulates pro-inflammatory mediators. Increased NF-κB activity has been associated with enhanced nociception and poorer recovery outcomes. Therefore, perioperative strategies that can reduce both pain and inflammatory response are of clinical importance.

Continuous erector spinae plane block (CESPB) is a regional anesthesia technique that provides multidermatomal analgesia by delivering local anesthetic into the fascial plane adjacent to the erector spinae muscle. Compared to single-shot techniques, CESPB using a catheter allows prolonged and stable analgesia. Ropivacaine is commonly used due to its favorable safety profile and potential anti-inflammatory effects.

This study is designed as a randomized controlled trial to compare CESPB using ropivacaine with standard analgesia without block in patients undergoing elective mastectomy. The primary outcome is postoperative pain intensity within 24 hours after surgery. Secondary outcomes include NF-κB levels, opioid consumption, incidence of postoperative nausea and vomiting, and quality of recovery measured using the QoR-15 questionnaire.

By integrating clinical and biomolecular outcomes, this study aims to provide comprehensive evidence regarding the effectiveness of CESPB not only in pain control but also in modulating the inflammatory response and improving postoperative recovery.

Вмешательства

• Процедура Continuous Erector Spinae Plane Block
  Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.
• Препарат Ropivacaine
  Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.

Первичные конечные точки

• Postoperative Pain Intensity [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (4)

• Change in Nuclear Factor Kappa B Levels From Baseline [Срок оценки: Baseline and 24 hours after surgery]
• Opioid Consumption [Срок оценки: 24 hours after surgery]
• Quality of Recovery [Срок оценки: 24 hours after surgery]
• Postoperative Nausea and Vomiting [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• Female patients aged 18 to 65 years
• Diagnosed with breast cancer
• Scheduled for elective mastectomy under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III
• Able to understand and provide written informed consent
• Body mass index (BMI) 18-29 kg/m²

Критерии исключения

• Contraindications to regional anesthesia
• Contraindications or allergy to ropivacaine or local anesthetics
• Inability to use a visual analog scale (VAS) for pain assessment
• Inability to understand or operate patient-controlled analgesia (PCA)
• History of chronic pain or ongoing infection requiring treatment
• History of chronic analgesic use
• History of autoimmune disease
• Uncontrolled systemic 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

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Ngoerah Hospital — Denpasar

Публикации

• Bajpai S, Kumar KS, Patibandla S, Giridhar CM. Ultrasound-guided continuous erector spinae plane block for perioperative opioid sparing analgesia in breast cancer surgery: A randomized controlled trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):327-333. doi: 10.4103/sja.sja_760_22. Epub 2023 Jun 22. PMID 37601522
• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PMID 27501016
• Zhang X, Xiang GR, Wang ZX, Peng MQ, Li M. Effect of dexmedetomidine-ropivacaine transversus abdominis plane block on analgesia and cognitive impairment risk in colorectal cancer surgery. World J Gastrointest Surg. 2025 Jun 27;17(6):102907. doi: 10.4240/wjgs.v17.i6.102907. PMID 40584511

Идентификаторы

NCT: NCT07562945 · CESPB-ALD-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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