Status:

RECRUITING

Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation

Lead Sponsor:

University Hospital, Gasthuisberg

Conditions:

Lung Transplant; Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal of this pilot trial is to learn whether the use of cryo nerve block and its effect on sensation in the chest alters recovery after bilateral lung transplantation, and to which extent these pa...

Eligibility Criteria

Inclusion

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  • Bilateral lung transplantation at UZ Leuven
  • Indication for transplantation: End stage chronic obstructive pulmonary disease (COPD)
  • Storage of lungs on classic ice, cooled system (LUNGguard® (Paragonix) or X°Port Lung Transport Device (Traferox Technologies Inc.) ) are all permitted
  • Patients that have undergone lung volume reduction or talcage are not a contraindication for participation in the study.

Exclusion

  • Unilateral lung transplantation
  • Lobar transplantation
  • Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
  • Combined organ transplantation
  • Chronic opioid use pre-operatively
  • Participation in an interventional Trial with an investigational medicinal product (IMP) or device (IMD) that could potentially influence the post-operative outcomes of this study

Key Trial Info

Start Date :

December 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06959056

Start Date

December 3 2025

End Date

December 1 2027

Last Update

December 9 2025

Active Locations (1)

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1

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium, 3000