Cryo nerve block to improve recovery after bilateral lung transplant
Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study
This pilot will test whether adding a cryo nerve block around the chest helps people with end-stage COPD recover better after a bilateral lung transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Gasthuisberg Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06959056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with end-stage COPD scheduled for bilateral lung transplantation at University Hospitals Leuven who can give informed consent and are not chronic preoperative opioid users are the intended participants.
Not a fit: Patients receiving unilateral or lobar transplants, combined organ transplants, donor lungs treated with EVLP, or those with chronic preoperative opioid use are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, cryo-analgesia could reduce postoperative chest pain and opioid use, shorten ICU stay, and improve overall recovery and quality of life after bilateral lung transplantation.
How similar studies have performed: Cryoanalgesia has shown short-term pain and opioid-sparing benefits in some thoracic surgery settings, but its application specifically after lung transplantation is novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven, Vlaams-Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.