Cryo Nerve Block Trial

Официальное название

A Randomized Controlled Trial Studying the Effect of Additional Intercostal Cryo-analgesia (ICCA) to Standard Postoperative Pain Management in Patients Undergoing Minimally Invasive Lung Surgery

Обзор

Background: Minimally invasive lung surgery, such as video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS), has become more common for lung resections because it leads to faster recovery, less pain, and shorter hospital stays. However, pain after surgery remains a major issue. Current guidelines suggest using a combination of pain management strategies to reduce the use of opioids and their side effects. Intercostal cryo-analgesia (ICCA), a technique that uses cold to reduce nerve activity, may help lower pain and opioid use after surgery. However, there is limited research on ICCA, with most studies having small sample sizes and lacking randomized controlled trials. More research is needed to compare ICCA with standard pain management in patients undergoing minimally invasive lung surgery. Objective: The goal of this study is to determine whether ICCA improves recovery compared to standard pain management after minimally invasive lung surgery. The investigators aim to measure recovery time and quality using the Quality of Recovery-15 (QoR-15) questionnaire. The investigators expect that ICCA will result in better recovery, less pain, reduced opioid use, and shorter hospital stays, without increasing the risk of nerve damage or other complications. Study Design: This will be a single-center, blinded, randomized controlled trial, along with an observational registry. Study Population: The study will include adults who are undergoing elective minimally invasive lung resections. Intervention: Patients in the intervention group will receive ICCA in addition to standard pain management after surgery. ICCA will be administered by the surgeon before closing the wound, targeting the intercostal nerves between ribs 3 and 7. Main Study Parameters/Endpoints: The primary outcome will be recovery time, measured using the QoR-15 questionnaire. The QoR-15 assesses overall recovery after surgery across several domains, with a score of 118 or higher indicating good recovery. The questionnaire is a reliable and valid tool for measuring postoperative recovery. Risks and Benefits: This trial will examine the effects of adding ICCA to the standard pain management protocol. Potential risks include numbness or nerve damage, neuropathic pain (pain caused by nerve injury), or complications such as bleeding (hematoma) or lung collapse (pneumothorax) at the treatment site. The potential benefits of ICCA include improved recovery, reduced opioid use, less pain, shorter hospital stays, and fewer respiratory complications after surgery.

Вмешательства

• Устройство Cryotherapy
  AtriCure's cryoICE cryoSPHERE probe will be inserted through one of the incisions used for VATS/RATS. Cryo-analgesia will be performed unilaterally on the intercostal nerves at levels T3-T7. Thus, cryo-analgesia will be applied at five intercostal levels. The probe will be placed at the inferior aspect of the ribs, posterior to the mid-axillary line, directly on the neurovascular bundle. One freezing cycle takes approximately 2 minutes, and a temperature between -50°C and -70°C will be applied.
• Препарат PAiN - multimodal analgesia
  Our standard postoperative pain management plan consists of intercostal nerve block, patient-controlled analgesia and acetaminophen

Первичные конечные точки

• Quality of Recovery [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Pain scores [Срок оценки: 6 months]
• Postoperative opioid consumption [Срок оценки: 6 months]
• Concomittant analgesia [Срок оценки: 6 months]
• Postoperative complications [Срок оценки: 6 months]
• Length of stay hospital [Срок оценки: 6 months]
• Operative time [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients are at least 18 years or older.
• Patients are electively scheduled to undergo minimally invasive (i.e., VATS or RATS) anatomical lung (i.e., pneumonectomy, (bi)lobectomy, or segmentectomy) resection for benign or malignant disease.
• Proficient understanding of the consequences of enrolment by the patients.
• Written informed consent by the patient.

Критерии исключения

• Patients with reported intolerance or hypersensitivity to the anaesthetic drug used for ICNB.
• Patients chronically using opioids for reasons not related to the operation (i.e., more than 3 months).
• Patients with liver failure inhibiting the systematic use of acetaminophen (i.e., paracetamol)
• Patients with connective tissue disease.
• Patients with comorbidities or history contra-indicating ICCA.
• Patients who are pregnant.
• Participation in other clinical trial(s) that may interfere with the current trial.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• St. Antonius Ziekenhuis — Nieuwegein

Идентификаторы

NCT: NCT06861387 · NL88359.100.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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