Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
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: Buprenorphine (BUP), Placebo.
- Кому может быть актуально
- Состояния в реестре: Postoperative Pain, Thoracic Surgery, Video-Assisted Thoracoscopic Surgery. 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
- Чили
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Analgesia With a 5 mcg/Hour Transdermal Buprenorphine Patch as Part of Multimodal Analgesia in Adults Undergoing Unilateral Video-Assisted Thoracoscopic Surgery: A Triple-Blind Randomized Controlled Trial
Обзор
Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.
Подробное описание
Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain that may impair respiratory function, delay recovery, prolong hospitalization, and contribute to the development of persistent postoperative pain. Current guidelines recommend multimodal analgesia, including non-opioid analgesics and regional anesthesia techniques, while opioids are generally reserved for rescue analgesia.
Transdermal buprenorphine is a long-acting partial μ-opioid receptor agonist that has demonstrated efficacy in reducing postoperative pain and opioid consumption in several surgical settings. However, evidence regarding its use in thoracic surgery is currently lacking.
This is a single-center, randomized, triple-blind, placebo-controlled clinical trial conducted at Clínica Dávila, Santiago, Chile. Adult patients undergoing unilateral video-assisted thoracoscopic surgery will be randomized in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia. Randomization will be computer-generated using sequentially numbered opaque sealed envelopes. Participants, investigators, outcome assessors, and the statistician will remain blinded to treatment allocation.
The primary outcome is postoperative pain intensity measured using the Numeric Rating Scale (0-10) at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue consumption expressed as morphine equivalents, postoperative nausea and vomiting, pruritus, urinary retention, and length of hospital stay. The planned sample size is 90 participants (45 per group).
Вмешательства
- Препарат Buprenorphine (BUP)
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia. - Другое Placebo
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
Первичные конечные точки
- Postoperative Pain Intensity Measured Using the Numeric Rating Scale [Срок оценки: 24, 48, and 72 hours and 7 days after surgery]
Вторичные конечные точки (5)
- Postoperative Rescue Opioid Consumption [Срок оценки: From the end of surgery through 7 days after surgery]
- Incidence of Postoperative Nausea and Vomiting [Срок оценки: 24, 48, and 72 hours and 7 days after surgery]
- Incidence of Postoperative Pruritus [Срок оценки: 24, 48, and 72 hours and 7 days after surgery]
- Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization [Срок оценки: 24, 48, and 72 hours and 7 days after surgery]
- Length of Hospital Stay [Срок оценки: From the day of surgery until hospital discharge, assessed up to 30 days]
Критерии участия
Критерии включения
- Adults aged 18 years or older.
- Scheduled for elective unilateral video-assisted thoracoscopic surgery (VATS).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent.
Критерии исключения
- Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
- Chronic opioid use before surgery.
- Severe hepatic impairment.
- Pregnancy or breastfeeding.
- Inability to complete postoperative pain assessments.
- Any condition that, in the investigator's opinion, could interfere with study participation or outcome assessment.
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
Чили · 1 центр
- Clínica Dávila — Santiago
Идентификаторы
NCT: NCT07733128 · CD2025/035