Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery
NCT ID: NCT05153083
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
200 participants
OBSERVATIONAL
2024-12-31
2026-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)
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.
Interventions
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Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)
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 Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Germano Melissano
OTHER
Responsible Party
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Germano Melissano
Prof
Locations
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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
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, , Portugal
University Hospital of Bern
Bern, , Switzerland
St Bartholomew's Hospital
London, , United Kingdom
Countries
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References
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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.
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.
Carlsson CA, Persson K, Pelletieri L. Painful scars after thoracic and abdominal surgery. Acta Chir Scand. 1985;151(4):309-11.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Cryo Registry
Identifier Type: -
Identifier Source: org_study_id
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