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Идёт набор NCT07694141

Postoperative Analgesia in Thoracic Surgery

Наблюдательное Postoperative Pain Management

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: Postoperative pain through Visual analogue scale, Postoperative complications.
Кому может быть актуально
Состояния в реестре: Postoperative Pain Management. Базовые параметры: от 18 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
Испания
Следующий шаг
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Официальное название

Postoperative Analgesia in Patients Undergoing Thoracic Surgery

Обзор

Analgesic management in thoracic surgery presents a particular challenge for the anesthesiologist, given the intensity of postoperative pain associated with thoracotomy, a surgical procedure that can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery. Study Population Design A prospective observational follow-up study will be conducted. ASA I-III patients undergoing scheduled thoracic surgery between November 1 and December 31, 2025, will be included. Their analgesic management will be based on standard clinical practice.

Подробное описание

The gold standard for managing pain after thoracic surgery is the administration of local anesthetics, with or without opioids, through a catheter placed in the epidural space during the 48-hour postoperative period. However, there are instances in which the placement of this catheter is contraindicated (due to patient refusal, coagulation disorders, spinal pathology, etc.) or in which the risk-benefit assessment necessitates the consideration of alternatives (it may lead to hypotension or bradycardia that compromises patients with cardiovascular disease, urinary retention, nerve injury, or spinal hematoma). This has prompted anesthesiologists to explore alternative options, including paravertebral block, which has shown promising results. However, it is important to note that paravertebral block is not entirely risk-free and has contraindications similar to those of epidural analgesia. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery.

Design and Study Population A prospective observational cohort study will be conducted. Patients will be followed from the day of hospital admission (usually 24 hours before surgery, when informed consent will be requested) until hospital discharge.

The management of perioperative analgesia will adhere to standard clinical protocols, following a comprehensive evaluation by the anesthesiologist responsible for intraoperative anesthesia management.

Patients with ASA I-III classification who have scheduled thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria between November 1 and December 31, 2025, will be included in the study. It is estimated that 80 patients will be included in this prospective, observational study.

On the day of the procedure, analgesic management will be administered according to the standard clinical practice of the anesthesiologist responsible for the patient's clinical management. The anesthesiologist will be unaware that the patient's perioperative analgesic management will be evaluated by this study. For all patients undergoing a regional procedure (epidural catheter or erector spinae plane block), standard aseptic measures will be followed during the procedure.

The epidural catheter will be placed according to standard clinical practice using the loss-of-resistance technique in the space between the dorsal spinous processes corresponding to the surgical wound site, prior to the patient's anesthesia induction. The anesthesiologist responsible for the patient's perioperative management will decide whether or not to use this catheter to administer analgesics during the intraoperative period or whether to administer intraoperative analgesics with or without the administration of intravenous opioids in combination with non-opioid analgesics.

For patients undergoing an erector spinae plane block, the procedure will be performed using ultrasound with a high-frequency linear ultrasound probe. The puncture point will be located 3 cm lateral to the spinous process. The puncture is made at the level of T5, in the craniocaudal plane, using a 50 mm EchoPlex needle, until the needle bevel is seen at the level of the transverse process, immediately anterior to the erector spinae muscle group. At this point, 3 ml of the local anesthetic selected by the anesthesiologist in charge of perioperative management of the patient is injected, allowing for the visualization of the dissection of the interfascial plane. If adequate dissection of this plane is confirmed during the injection of these 3 ml, the remaining local anesthetic will be injected until the target volume is reached, without exceeding the toxic dose for each patient. 7) Intraoperative anesthetic management will be carried out in accordance with standard clinical practice. Following the completion of the procedure and extubation, the patient will be transferred to the Post-Anesthesia Care Unit. Pain will be assessed using a numerical pain scale at 1, 3, 6, 24, and 48 hours postoperatively. Postoperative management will be carried out according to standard clinical practice. The patient's postoperative progress will also be assessed until hospital discharge.

Вмешательства

  • Диагностический тест Postoperative pain through Visual analogue scale
    Postoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively.
  • Диагностический тест Postoperative complications
    The patient's postoperative evolution will be assessed until hospital discharge, in order to define the appearance of postoperative complications classified according to Clavien-Dindo classification.

Первичные конечные точки

  • Postoperative pain [Срок оценки: 24 postoperative hours]
Вторичные конечные точки (2)
  • Postoperative analgesics consumption [Срок оценки: 24 postoperative hours.]
  • Postoperative complications [Срок оценки: First postoperative week.]

Критерии участия

Критерии включения

  • Patients undergoing thoracic surgery between July 1 and October 31, 2020.
  • Age over 18.
  • ASA I-III.
  • Signed informed consent

Критерии исключения

  • ASA IV-V.
  • Chronic opioid treatment or treatment in the Chronic Pain Unit.
  • Intravenous drug abuse.
  • Local anesthetic allergy.
  • Language barrier, cognitive impairment, or inability to participate in clinical assessment during the study.
  • BMI <18 or >35 kg/m2

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria

Идентификаторы

NCT: NCT07694141 · 2020-339-1

Первоисточники (государственные реестры)

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