Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Aneurysm

Intervention / Treatment
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* Procedure: Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)<br>Subjects undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA) using cryoablation of intercostal nerves | Procedure: Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)<br>* Each participating center will be able to use its preferred European Conformity marked device, for cryoablation according to their normal clinical practice and according to the instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success | Freedom from Death | From Admission to 1 years | 
| change in dose of narcotic administration | reduction opioids usage for thoracic incision pain | From Admission to 1 years | 
| Primary clinical success | pain control defined as a visual analogic scale < 5 in the perioperative period up to the discharge | up to 3 weeks | 
| secondary clinical success | pain control in in the perioperative period up to the discharge, using analgesic non opioids drugs | up to 3 weeks |