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

Aneurysm Clinical Trial

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05153083
• Other study ID #: Cryo Registry
• Status: Suspended
• Start date: December 31, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: January 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Pain, Postoperative

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Austria	Hospital Hietzing,Vienna	Vienna
France	Salpetriere University Hospital	Paris
Germany	University Hospital Freiburg	Freiburg
Germany	University Medical Center Hamburg	Hamburg
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Hannover Medical School	Hannover
Germany	Saarland University Hospital	Homburg
Italy	Policlinico S. Orsola - Malpighi	Bologna
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Netherlands	Maastricht University Medical Center	Maastricht
Portugal	Centro Hospitalar de Entre o Douro e Vouga	Santa Maria Da Feira
Switzerland	University Hospital of Bern	Bern
United Kingdom	St Bartholomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Germano Melissano

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

References & Publications (10)

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. — View Citation

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

Outcome

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