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Идёт набор NCT06569953

Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial

Фаза IV С лечением Acute Pain Chronic Pain 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: Liposomal bupivacaine, Bupivacaine Hydrochloride.
Кому может быть актуально
Состояния в реестре: Acute Pain, Chronic Pain, Postoperative Pain. 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
Китай
Следующий шаг
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Обзор

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

Подробное описание

Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.

Вмешательства

  • Препарат Liposomal bupivacaine
    Participants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline).
  • Препарат Bupivacaine Hydrochloride
    Participants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline)

Первичные конечные точки

  • Area under the movement-evoked pain intensity-time curve [Срок оценки: from 0-72 hours after the intervention]
  • The incidence of chronic postoperative pain [Срок оценки: postoperative day (POD) 90]
Вторичные конечные точки (10)
  • Area under the rest pain intensity-time curve [Срок оценки: from 0-72 hours after the intervention]
  • Movement-evoked pain score [Срок оценки: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention]
  • Pain score at rest [Срок оценки: 30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention]
  • Proportion of participants who did not use rescue analgesia [Срок оценки: from 0-72 hours after the intervention]
  • The cumulative dosage of rescue analgesia [Срок оценки: from 0-72 hours after the intervention]
  • The time of first use of rescue analgesia [Срок оценки: from 0-72 hours after the intervention]
  • First time out-of-bed [Срок оценки: From date of surgery until the date of first out-of-bed，assessed up to 7 days]
  • Length of hospital stay [Срок оценки: From date of surgery until the date of first hospital discharge，assessed up to 1 months]
  • Chronic pain score [Срок оценки: postoperative day (POD) 90]
  • Score of satisfaction with analgesia [Срок оценки: At 72 hours after the intervention]

Критерии участия

Критерии включения

  • Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
  • Participants were 18 years or older.
  • 18 kg/m2≤BMI≤30 kg/m2
  • Participants with American Society of Anesthesiology (ASA) physical status I-III.
  • Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.

Критерии исключения

  • with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
  • with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
  • with sensory disorders such as hyperalgesia.
  • with other bodily pain.
  • allergy to amide-type local anesthetics or any of the trial drugs
  • taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(NSAIDs),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h.
  • with a history of alcohol or opioid abuse.
  • who were pregnant or lactating.
  • who were currently included in another clinical study within 3 months.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT06569953 · LBPB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗