Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery - A Physician-initiated, International, Multicentre, Prospective, Observational Registry of Patients Undergoing Open Thoracic (TAA) and Thoracoabdominal Aortic Aneurysms Repair (TAAA) Using Cryoablation of Intercostal Nerves to Improve Postoperative Pain Control. (Cryo Registry)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- change in dose of narcotic administration
研究概览
简要总结
The purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair.
The cryoablation procedure is one of the opportunities for pain control after thoracotomy. So, it is routinely performed in major several centers in aortic surgery around the world as a part of the TAA and TAAA procedure.
The Registry will include approximately 200 patients treated from January 2022 to January 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until January 2027.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥18 years
- •Patients who will undergo TAA and TAAA open repair with intraoperative intercostal nerves cryoablation
- •Subject has consented for study participation and signed the approved Informed Consent
排除标准
- •Patients with active systemic or cutaneous infection or inflammation
- •Patients who are pregnant or breastfeeding
- •Patients younger than 18 years of age
- •Unwilling or unable to comply with the follow-up schedule
- •Inability or refusal to give informed consent
- •Frank rupture
- •Previous stroke with neurological sequelae
结局指标
主要结局
change in dose of narcotic administration
时间窗: From Admission to 1 years
reduction opioids usage for thoracic incision pain
technical success
时间窗: From Admission to 1 years
Freedom from Death
Primary clinical success
时间窗: up to 3 weeks
pain control defined as a visual analogic scale \< 5 in the perioperative period up to the discharge
secondary clinical success
时间窗: up to 3 weeks
pain control in in the perioperative period up to the discharge, using analgesic non opioids drugs
次要结局
未报告次要终点
研究者
Germano Melissano
Prof
IRCCS San Raffaele