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Набор скоро начнётся NCT07729488

ESPB Versus SPSIPB for Quality of Recovery After Video-Assisted Thoracoscopic Surgery

Без фазы С лечением Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ESPB, SPSIPB.
Кому может быть актуально
Состояния в реестре: Postoperative Pain. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Quality of Recovery After Video-Assisted Thoracoscopic Surgery: A Randomized Double-Blind Trial

Обзор

Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain despite its minimally invasive nature. Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are promising regional analgesic techniques for thoracic surgery; however, evidence directly comparing their effects on postoperative quality of recovery remains limited. This prospective, randomized, double-blind controlled trial aims to compare the effects of ESPB and SPSIPB on postoperative quality of recovery, measured by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes include postoperative pain scores, tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, patient satisfaction, length of hospital stay, block-related complications, and perioperative hemodynamic parameters.

Подробное описание

Video-assisted thoracoscopic surgery (VATS) has become the preferred surgical approach for many thoracic procedures because of its minimally invasive nature. Nevertheless, patients frequently experience moderate to severe postoperative pain, which may impair respiratory function, delay mobilization, prolong hospitalization, and negatively affect overall recovery. Effective multimodal analgesia is therefore essential for optimizing postoperative outcomes.

Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are interfascial plane blocks that have demonstrated promising analgesic efficacy in thoracic surgery. Although both techniques are increasingly used in clinical practice, evidence directly comparing their effects on postoperative quality of recovery following VATS is limited.

This prospective, randomized, double-blind, parallel-group clinical trial will enroll 128 adult patients (18-70 years, ASA physical status I-III) undergoing elective VATS. Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided ESPB or ultrasound-guided SPSIPB before surgery.

The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include postoperative pain scores at rest and during coughing, cumulative 24-hour tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, sedation level, patient satisfaction, length of hospital stay, block-related complications, perioperative hemodynamic variables, and additional analgesic requirements.

The results of this study are expected to provide high-quality evidence regarding the comparative effectiveness of ESPB and SPSIPB in improving postoperative recovery and analgesic outcomes after VATS and may contribute to optimizing regional analgesia strategies for thoracic surgery.

Вмешательства

  • Процедура ESPB
    An ultrasound-guided erector spinae plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery. The block will be performed using the standardized study protocol.
  • Процедура SPSIPB
    An ultrasound-guided serratus posterior superior intercostal plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery. The block will be performed using the standardized study protocol.

Первичные конечные точки

  • Quality of Recovery-15 (QoR-15) Score [Срок оценки: 24 hours after surgery]
Вторичные конечные точки (9)
  • Postoperative Pain at Rest [Срок оценки: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.]
  • Postoperative Pain Intensity During Coughing [Срок оценки: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.]
  • Time to First Rescue Analgesia [Срок оценки: During the first 24 hours after surgery]
  • Cumulative Postoperative Tramadol Consumption [Срок оценки: During the first 24 hours after surgery]
  • Requirement for Rescue Analgesia [Срок оценки: During the first 24 hours after surgery]
  • Postoperative Nausea and Vomiting Impact Score [Срок оценки: During the first 24 hours after surgery]
  • Patient Satisfaction With Postoperative Analgesia [Срок оценки: 24 hours after surgery]
  • Postoperative Length of Hospital Stay [Срок оценки: From surgery until hospital discharge (up to 30 days)]
  • Incidence of Block-Related Complications [Срок оценки: From block performance until hospital discharge (up to 30 days)]

Критерии участия

Критерии включения

  • Adults aged 18-85 years.
  • ASA physical status I-III.
  • Scheduled for elective VATS under general anesthesia.
  • Able to understand and complete the QoR-15 questionnaire.
  • Written informed consent provided.

Критерии исключения

  • Refusal to participate or inability to provide written informed consent.
  • Known allergy or contraindication to bupivacaine, paracetamol, dexketoprofen, or tramadol.
  • Infection at the planned block injection site.
  • Coagulopathy or ongoing anticoagulant therapy precluding regional anesthesia.
  • Severe hepatic or renal insufficiency.
  • Chronic opioid use or chronic pain requiring regular analgesic treatment.
  • Previous thoracic surgery on the operative side.
  • Pregnancy or breastfeeding.
  • Cognitive impairment, psychiatric illness, or language barrier preventing completion of the QoR-15 questionnaire.
  • Body mass index (BMI) >35 kg/m².
  • Conversion from VATS to thoracotomy.
  • Failed or incomplete regional block.

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
  • Fatma Acil — Diyarbakır
  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital — Diyarbakır

Идентификаторы

NCT: NCT07729488 · 07/20/2026-xxx

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗