Intrathecal Morphine for Recovery and Outcomes After VATS

Официальное название

The Effects of Intrathecal Morphine in Addition to Serratus Anterior Plane Block and Dexmedetomidine on Postoperative Recovery (QoR-15) and Systemic Inflammation in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

Обзор

This study will compare two different methods of pain management in patients undergoing video-assisted thoracoscopic surgery (VATS). One group will receive a combination of spinal morphine, nerve block, and dexmedetomidine, while the other group will receive a nerve block and dexmedetomidine without spinal morphine. All patients will receive standard pain medications after surgery. The purpose is to see if adding spinal morphine improves pain control and recovery after surgery.

Подробное описание

This is a single-center, prospective, randomized, double-blind clinical trial evaluating the efficacy of intrathecal morphine in combination with serratus anterior plane block (SAPB) and dexmedetomidine infusion for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS). Eligible patients are ASA I-II, aged 18-70 years, with BMI \< 35 kg/m². Patients will be randomized into two groups using a computer-generated sequence. The intervention group will receive intrathecal morphine (200 µg) in addition to SAPB and dexmedetomidine, while the control group will receive SAPB and dexmedetomidine alone. The primary outcome is postoperative pain scores (VAS) within the first 24 hours. Secondary outcomes include opioid consumption, quality of recovery, and incidence of side effects.

Вмешательства

• Препарат Intrathecal Morphine
  200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.
• Процедура Serratus Anterior Plane Block (SAPB) group
  Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.
• Препарат Dexmedetomidine
  Loading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.

Первичные конечные точки

• Quality of Recovery-15 (QoR-15) Score [Срок оценки: Measured 24 hours after surgery]

Вторичные конечные точки (11)

• Time to First Rescue Opioid [Срок оценки: Within 24 hours postoperatively]
• Postoperative Pain Scores (VAS) [Срок оценки: From postoperative hour 2 to hour 24.]
• Total Opioid Consumption [Срок оценки: 24 hours postoperatively]
• Intraoperative Complications [Срок оценки: During surgery]
• Postoperative Adverse Effects [Срок оценки: 24 hours postoperatively]
• Serum Interleukin-6 (IL-6) Level [Срок оценки: Preoperatively and at 24 hours postoperatively]
• Neutrophil-to-Lymphocyte Ratio (NLR) [Срок оценки: Preoperatively and at 24 hours postoperatively]
• Serum C-reactive Protein (CRP) Level [Срок оценки: Preoperatively and at 24 hours postoperatively.]
• Platelet-to-Lymphocyte Ratio (PLR) [Срок оценки: Preoperatively and at 24 hours postoperatively.]
• Lymphocyte-to-Monocyte Ratio (LMR) [Срок оценки: Preoperatively and at 24 hours postoperatively.]
• Systemic Immune-Inflammation Index (SII) [Срок оценки: Preoperatively and at 24 hours postoperatively.]

Критерии участия

Критерии включения

• Elective video-assisted thoracoscopic surgery (VATS) planned
• Age 18-70 years
• ASA physical status I-III
• Body mass index (BMI) <35 kg/m²

Критерии исключения

• Coagulopathy
• Opioid dependence or intolerance
• Allergy to local anesthetics
• Contraindications to neuraxial blockade
• Chronic pain history
• Renal or hepatic failure

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) · 2 центра

• Ataturk University — Erzurum
• Ataturk University — Erzurum

Публикации

• Jiao Y, Zhang X, Liu M, Sun Y, Ma Z, Gu X, Gu W, Zhu W. Systemic immune-inflammation index within the first postoperative hour as a predictor of severe postoperative complications in upper abdominal surgery: a retrospective single-center study. BMC Gastroenterol. 2022 Aug 27;22(1):403. doi: 10.1186/s12876-022-02482-9. PMID 36030214
• Xu N, Zhang JX, Zhang JJ, Huang Z, Mao LC, Zhang ZY, Jin WD. The prognostic value of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in colorectal cancer and colorectal anastomotic leakage patients: a retrospective study. BMC Surg. 2025 Feb 5;25(1):57. doi: 10.1186/s12893-024-02708-5. PMID 39910526
• Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342. PMID 26135695
• Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5. PMID 32316949
• Yoon SH, Bae J, Yoon S, Na KJ, Lee HJ. Correlation Between Pain Intensity and Quality of Recovery After Video-Assisted Thoracic Surgery for Lung Cancer Resection. J Pain Res. 2023 Oct 2;16:3343-3352. doi: 10.2147/JPR.S426570. eCollection 2023. PMID 37808464
• Mugabure Bujedo B. A clinical approach to neuraxial morphine for the treatment of postoperative pain. Pain Res Treat. 2012;2012:612145. doi: 10.1155/2012/612145. Epub 2012 Jul 2. PMID 23002426
• Sibanyoni M, Biyase N, Motshabi Chakane P. The use of intrathecal morphine for acute postoperative pain in lower limb arthroplasty surgery: a survey of practice at an academic hospital. J Orthop Surg Res. 2022 Jun 21;17(1):323. doi: 10.1186/s13018-022-03215-0. PMID 35729586
• Meng G, Chen W, Shi D, Mei B, Liu X. Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing single-port video-assisted thoracoscopic surgery: A randomized prospective trial. J Clin Anesth. 2025 Sep;106:111950. doi: 10.1016/j.jclinane.2025.111950. Epub 2025 Jul 31. PMID 40749388

Идентификаторы

NCT: NCT07231926 · B.30.2.ATA.0.01.00/614 · 2025/2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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