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

Suspended

• Conditions: Aneurysm
• Interventions: Procedure: Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)

• Registration Number: NCT05153083
• Lead Sponsor: Germano Melissano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Study Start: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)	Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)	Subjects undergoing open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA) using cryoablation of intercostal nerves

Primary Outcome Measures

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

Trial Locations

Locations (13)

Hospital Hietzing,Vienna; 🇦🇹 Vienna, Austria

Centro Hospitalar de Entre o Douro e Vouga; 🇵🇹 Santa Maria Da Feira, Portugal

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

University Medical Center Hamburg; 🇩🇪 Hamburg, Germany

Salpetriere University Hospital; 🇫🇷 Paris, France

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

Saarland University Hospital; 🇩🇪 Homburg, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy

University Hospital of Bern; 🇨🇭 Bern, Switzerland

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom