Serratus Posterior Superior Intercostal Plane Block Versus Intrathecal Morphine in VATS

Официальное название

Comparison of the Effects of Serratus Posterior Superior Intercostal Plane Block and Intrathecal Morphine on Postoperative Acute Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery

Обзор

This study aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery. This is a prospective, randomized, controlled, single-center clinical trial including adult patients undergoing elective thoracoscopic surgery. Participants will be randomly assigned to receive either a serratus posterior superior intercostal plane block or intrathecal morphine before general anesthesia. The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents. Secondary outcomes include pain scores, time to first analgesic request, quality of recovery, and postoperative complications. The study aims to determine whether these two techniques differ in their effectiveness for postoperative pain management.

Подробное описание

This study is a prospective, randomized, controlled, single-blinded, parallel-group clinical trial designed to compare the analgesic efficacy of serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.

Eligible patients aged 18-75 years with American Society of Anesthesiologists physical status I-III scheduled for elective thoracoscopic procedures (wedge resection, segmentectomy, or lobectomy) will be included. Patients will be randomized in a 1:1 ratio using a computer-generated sequence with block randomization.

Participants in the serratus posterior superior intercostal plane block group will receive an ultrasound-guided regional block prior to the induction of general anesthesia. Participants in the intrathecal morphine group will receive an intrathecal morphine injection before general anesthesia. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia.

The primary outcome is cumulative opioid consumption within the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents.

Secondary outcomes include opioid consumption at 12 hours, numeric rating scale pain scores at rest and during activity, time to first analgesic request, quality of recovery scores, postoperative nausea and vomiting, sedation levels, pruritus, respiratory depression, and postoperative complications up to 30 days.

This study aims to evaluate the relative effectiveness of these two analgesic techniques and to improve postoperative pain management strategies in thoracic surgery.

Вмешательства

• Процедура Intrathecal Morphine
  Preservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally before induction of general anesthesia.
• Процедура Serratus Posterior Superior Intercostal Plane Block
  Ultrasound-guided serratus posterior superior intercostal plane block is performed before induction of general anesthesia using 30 milliliters of 0.25 percent bupivacaine with epinephrine injected into the interfascial plane between the serratus posterior superior muscle and intercostal muscles.

Первичные конечные точки

• Cumulative IV-MME during the first 24 hours after postoperative admission following extubation [Срок оценки: 24 hours]

Вторичные конечные точки (12)

• Cumulative IV-MME during the first 12 hours after postoperative admission following extubation [Срок оценки: 12 hours]
• Postoperative pain scores [Срок оценки: 0, 3, 6, 12, 18, and 24 hours postoperatively]
• Time to first patient-controlled analgesia demand [Срок оценки: 24 hours]
• Quality of recovery score [Срок оценки: Preoperative baseline, 24 hours postoperatively, and at discharge]
• Postoperative nausea and vomiting [Срок оценки: 0, 3, 6, 12, 18, and 24 hours postoperatively]
• Sedation level [Срок оценки: 0, 3, 6, 12, 18, and 24 hours postoperatively]
• Respiratory depression [Срок оценки: 24 hours]
• Pruritus [Срок оценки: 0, 3, 6, 12, 18, and 24 hours postoperatively]
• Block-related complications [Срок оценки: Up to 30 days postoperatively]
• Postoperative complications [Срок оценки: 30 days]
• Remifentanil consumption [Срок оценки: Intraoperative period (from induction to end of surgery), up to 4 hours]
• Rescue analgesia requirement [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• Age between 18 and 75 years
• American Society of Anesthesiologists physical status I to III
• Scheduled for elective video-assisted thoracoscopic surgery, including wedge resection, segmentectomy, or lobectomy

Критерии исключения

• Refusal to participate
• Pregnancy
• Morbid obesity (body mass index greater than 40 kg per square meter)
• Allergy to study medications
• Neuropsychiatric disorders, cognitive impairment, or inability to communicate
• History of substance abuse
• Active systemic infection or infection at the planned injection site
• Severe cardiac, respiratory, hepatic, renal, or endocrine disease.
• Chronic pain syndrome or ongoing chronic pain treatment
• Emergency surgery or previous ipsilateral VATS or thoracotomy
• Preoperative opioid use: ≥15 mg oral morphine equivalents/day for ≥30 days within the previous 3 months.
• Anticipated need for postoperative mechanical ventilation.
• Contraindications to neuraxial or peripheral regional anesthesia, including anticoagulant therapy, coagulopathy, infection, or relevant anatomical abnormalities.

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

Turkey (Türkiye) · 1 центр

• Ondokuz Mayis University — Atakent

Идентификаторы

NCT: NCT07540104 · SPSIPITM1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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