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

Germano Melissano

Status: Suspended

Conditions: Aneurysm

Treatments: Procedure: Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)

Study type: Observational

Funder types: Other

Identifiers

NCT05153083

Cryo Registry

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

patient undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)

Description:

Subjects undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA) using cryoablation of intercostal nerves

Treatment:

Procedure: Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)