Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy

Обзор

The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. The main questions it aims to answer are: * Does continuous ESPB lower the intensity of postoperative pain compared to multimodal intravenous analgesia? * Does continuous ESPB increase the time to first analgesic request? * Does continuous ESPB reduce the amount of intravenous opioids required in the first 48 hours after surgery? * Does continuous ESPB improve the overall recovery quality within 48 hours post-surgery? Participants will: * Receive continuous ESPB or multimodal intravenous analgesia after the surgery. * Undergo routine pain assessments, and recovery evaluations using tools like the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Подробное описание

For the Continuous ESPB Group, patients will receive continuous ESPB, NSAIDs, Paracetamol, and Morphine using Patient Controlled Analgesia (PCA) with a demand only mode.

For the Intravenous Opioid, patient will receive Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Paracetamol, and Morphine using Patient Controlled Analgesia (PCA).

Вмешательства

• Процедура Continuous Erector Spinae Plane Block
  Catheter are placed between the erector spinae muscle and the transversus processus with ultrasound guidance, blocking the dorsal and ventral ramus from the thorax and abdominal spinal nerves, at the level of T5. Local anesthesia is injected. Drugs used are Bupivacaine 0.25% with volume of 25 ml.
• Препарат Multimodal Intravenous Analgesia
  Multimodal intravenous analgesia refers to the use of multiple intravenous (IV) agents with different mechanisms of action to provide effective pain relief. The goal is to achieve synergistic effects that improve analgesia while minimizing the doses of individual drugs, thereby reducing side effects. This approach is often used in perioperative and acute pain management. Patient will receive combinations of opioid through Patient Controlled Analgesia (PCA) device, NSAIDs, and Paracetamol (Aceta

Первичные конечные точки

• Resting Pain Score 24 hours [Срок оценки: 24 hours]
• Resting Pain Score 48 hours [Срок оценки: 48 hours]
• Coughing Pain Score 24 hours [Срок оценки: 24 hours]
• Coughing Pain Score 48 hours [Срок оценки: 48 hours]

Вторичные конечные точки (6)

• Time to First Analgesia [Срок оценки: 48 hours]
• Opioid Consumption 24 hours [Срок оценки: 24 hours]
• Opioid Consumption 48 hours [Срок оценки: 48 hours]
• Quality of Recovery Preoperative [Срок оценки: At enrollment]
• Quality of Recovery 24 hours [Срок оценки: 24 hours]
• Quality of Recovery 48 hours [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Patients of 21-65 years of age
• Undergoing Unilateral Thoracotomy Operation

Критерии исключения

• Patients with ASA Physical Status > III
• Obese or Underweight Patients with BMI of less than 18.5 or more than 29.99
• Patients with contraindications to be given local anesthesia drugs
• Patients with contraindications to be given opioid drugs
• Patients refused to participate

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

Индонезия · 1 центр

• RSUP Prof. dr. I.G.N.G. Ngoerah — Denpasar

Публикации

• Moorthy A, Ni Eochagain A, Dempsey E, Wall V, Marsh H, Murphy T, Fitzmaurice GJ, Naughton RA, Buggy DJ. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial. Br J Anaesth. 2023 Jan;130(1):e137-e147. doi: 10.1016/j.bja.2022.07.051. Epub 2022 Sep 13. PMID 36109206
• Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available. PMID 37465231
• Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29. PMID 34301447
• Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789. PMID 29746445
• Gupta R, Van de Ven T, Pyati S. Post-Thoracotomy Pain: Current Strategies for Prevention and Treatment. Drugs. 2020 Nov;80(16):1677-1684. doi: 10.1007/s40265-020-01390-0. PMID 32876936
• 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
• Fawzi Hanna, M.E., Abdel Latif, S.A.M., Hussien Maamoon, R.M., Abdel-Mouty Taher, I.A.-A., 2024. Erector Spinae Plane Block for Postoperative Analgesia after Video-Assisted Thoracoscopic Surgery (VATS). QJM: An International Journal of Medicine 117, hcae070.062. https://doi.org/10.1093/qjmed/hcae070.062
• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4. PMID 30621377

Идентификаторы

NCT: NCT06750627 · 2708/UN14.2.2.VII.14/LT/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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