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

Germano Melissano200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Aneurysm

Interventions

Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Hospital Hietzing,Vienna

Vienna, Austria

Salpetriere University Hospital

Paris, France

University Hospital Freiburg

Freiburg im Breisgau, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

University Medical Center Hamburg

Hamburg, Germany

Hannover Medical School

Hanover, Germany

Saarland University Hospital

Homburg, Germany

Policlinico S. Orsola - Malpighi

Bologna, Italy, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, Italy

Maastricht University Medical Center

Maastricht, Netherlands

...and 3 more locations

Outcomes

Primary Outcomes

technical success

Freedom from Death

Time frame: From Admission to 1 years

change in dose of narcotic administration

reduction opioids usage for thoracic incision pain

Time frame: 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

Time frame: up to 3 weeks

secondary clinical success

pain control in in the perioperative period up to the discharge, using analgesic non opioids drugs

Time frame: up to 3 weeks