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

NCT05153083 | Suspended

• 1 other identifier: Cryo Registry
• Study Type: observational
• Target: 200
• Locations: 8 countries
• Sites: 13

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.

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

patient undergoing 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

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Germano Melissano: lead

Study Sites (13)

Hospital Hietzing,Vienna

Vienna, Austria

Location

Salpetriere University Hospital

Paris, France

Location

University Hospital Freiburg

Freiburg im Breisgau, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

University Medical Center Hamburg

Hamburg, Germany

Location

Hannover Medical School

Hanover, Germany

Location

Saarland University Hospital

Homburg, Germany

Location

Policlinico S. Orsola - Malpighi

Bologna, Italy, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, Italy

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, Portugal

Location

University Hospital of Bern

Bern, Switzerland

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Related Publications (10)

• Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

  PMID: 8722735 BACKGROUND

• Richardson J, Sabanathan S, Shah R. Post-thoracotomy spirometric lung function: the effect of analgesia. A review. J Cardiovasc Surg (Torino). 1999 Jun;40(3):445-56.

  PMID: 10412938 BACKGROUND

• Carlsson CA, Persson K, Pelletieri L. Painful scars after thoracic and abdominal surgery. Acta Chir Scand. 1985;151(4):309-11.

  PMID: 4036485 BACKGROUND

• Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7.

  PMID: 12683601 BACKGROUND

• Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. doi: 10.1097/00000542-200603000-00027. No abstract available.

  PMID: 16508407 BACKGROUND

• Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20.

  PMID: 31972300 BACKGROUND

• Johnston KW, Rutherford RB, Tilson MD, Shah DM, Hollier L, Stanley JC. Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg. 1991 Mar;13(3):452-8. doi: 10.1067/mva.1991.26737.

  PMID: 1999868 BACKGROUND

• Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. doi: 10.1067/mva.2002.123991. No abstract available.

  PMID: 12021728 BACKGROUND

• Achouh PE, Madsen K, Miller CC 3rd, Estrera AL, Azizzadeh A, Dhareshwar J, Porat E, Safi HJ. Gastrointestinal complications after descending thoracic and thoracoabdominal aortic repairs: a 14-year experience. J Vasc Surg. 2006 Sep;44(3):442-6. doi: 10.1016/j.jvs.2006.05.018.

  PMID: 16950413 BACKGROUND

• Riambau V, Bockler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005. No abstract available.

  PMID: 28081802 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 10, 2021
• Study Start: December 31, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

IT (2); NL (1); DE (5); GB (1); FR (1); PT (1); AU (1); CH (1)