Clinical trial NCT05153083: Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery
Official title: Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery - A Physician-initiated, International, Multicentre, Prospective, Observational Registry of Patients Undergoing Open Thoracic (TAA) and Thoracoabdominal Aortic Aneurysms Repair (TAAA) Using Cryoablation of Intercostal Nerves to Improve Postoperative Pain Control. (Cryo Registry)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Aneurysm
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: technical success
timeFrame: From Admission to 1 years
measure: change in dose of narcotic administration
timeFrame: From Admission to 1 years
measure: Primary clinical success
timeFrame: up to 3 weeks
measure: secondary clinical success
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital Hietzing,Vienna
city: Paris
country: France
facility: Salpetriere University Hospital
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Homburg
country: Germany
facility: Saarland University Hospital
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga
city: Bern
country: Switzerland
facility: University Hospital of Bern
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: Carlsson CA, Persson K, Pelletieri L. Painful scars after thoracic and abdominal surgery. Acta Chir Scand. 1985;151(4):309-11.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.