Cryo nerve block to improve recovery after bilateral lung transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study delivers cryo-analgesia to the T3–T8 intercostal nerves bilaterally at the time of bilateral lung transplantation to alter chest sensation and postoperative pain. It will compare patients receiving the cryo nerve block with standard care and measure highest pain scores, opioid (morphine) requirements, lung function, ICU length of stay, complications, and quality of life in both short and long term. The study is designed to estimate effect sizes and identify which outcomes may be impacted to inform larger trials rather than to provide definitive efficacy results. All procedures and follow-up take place at a single high-volume European transplant center (University Hospitals Leuven) in adults with end-stage COPD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Unilateral lung transplantation
2. Lobar transplantation
3. Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
4. Combined organ transplantation
5. Chronic opioid use pre-operatively
6. 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

Where it's running

• University Hospitals Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Hans Van Veer, MD — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Hans Van Veer, MD
• Email: hans.vanveer@uzleuven.be
• Phone: +3216346822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.