Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation

Официальное название

Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study

Обзор

The goal of this pilot trial is to learn whether the use of cryo nerve block and its effect on sensation in the chest alters recovery after bilateral lung transplantation, and to which extent these parameters are influenced. As this study is setup as a pilot study, the main questions it aims to determine the potential impacted parameters as well as their effect sizes, of cryo-analgesia on both short and long term outcomes following bilateral lung transplantation in COPD patients in a European high volume lung transplant centre. The efficacy parameters under evaluation will be: * is the highest pain score affected by the use of cryo nerve block? * Is there an effect on the lung function ? * Does cryo nerve block cause specific complications? * are patients treated with cryo nerve block still needing the same amount of morphine as a pain killer? * is the length of stay in intensive care influenced by the use of cryo nerve block? * and is the qualiy of life influenced by the use of cryo nerve block? Participants will: * undergo cryo nerve block or receive routine pain treatment after bilateral lung transplantation * be followed up during the first week after the operation, and every month to determine their pain * be asked to perform a lung function test and complete quality of life questionnaires 1, 2, 3, 6 months and 1 year after transplantation

Вмешательства

• Устройство cryo nerve block at T3-T8 intercostal nerves bilaterally
  In order to obtain better analgesia at the level of the chest wall, where the chest is bilaterally opened for lung extraction and donor lung implantation, intraoperative cryo-ablation will be applied to the intercostal nerves at the bilateral intercostal spaces 3-8, 3cm lateral to the sympathetic chain, under direct visualization during surgery, as such covering 2 intercostal levels above as well as below the normal access of ICR 4 or 5. By providing analgesia to level 8, we will also cover the

Первичные конечные точки

• Visual Analogue pain Scale value [Срок оценки: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative]
• Lung function [Срок оценки: 1, 2, 3, 6 and 12 months postoperative]
• opioid consumption [Срок оценки: postoperative days 1-7, and every monthly contact until 1 year postoperative]
• Length of stay (LOS) at ICU [Срок оценки: from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative]
• Total hospital length of stay (HLOS) [Срок оценки: from treatment until last day in the hospital of the index admission, between 2 days and 6 months postoperative]
• Evaluation of Quality of life - SF12 [Срок оценки: single time points at 1, 2, 3, 6 months and 1 year postoperative]
• Evaluation of Quality of life - EQ5D5L [Срок оценки: single time points at 1, 2, 3, 6 months and 1 year postoperative]
• Evaluation of Quality of life - Brief Pain Inventory [Срок оценки: single time points at 1, 2, 3, 6 months and 1 year postoperative]
• Evaluation of Neuropathic Pain [Срок оценки: single time points at 1, 2, 3, 6 months and 1 year postoperative]

Критерии участия

Критерии включения

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Bilateral lung transplantation at UZ Leuven
• Indication for transplantation: End stage chronic obstructive pulmonary disease (COPD)
• Storage of lungs on classic ice, cooled system (LUNGguard® (Paragonix) or X°Port Lung Transport Device (Traferox Technologies Inc.) ) are all permitted
• Patients that have undergone lung volume reduction or talcage are not a contraindication for participation in the study.

Критерии исключения

• Unilateral lung transplantation
• Lobar transplantation
• Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
• Combined organ transplantation
• Chronic opioid use pre-operatively
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device (IMD) that could potentially influence the post-operative outcomes of this study

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospitals Leuven — Leuven

Идентификаторы

NCT: NCT06959056 · S68933 · U1111-1320-5059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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