RecruitingNot Applicable

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

Belgium40 participantsStarted 2026-01-04

Plain-language 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 parameters are influenced. As this study is setup as a pilot study, the main questions it aims to determine the potential impacted parameters as well as their effect sizes, of cryo-analgesia on both short and long term outcomes following bilateral lung transplantation in COPD patients in a European high volume lung transplant centre. The efficacy parameters under evaluation will be: * is the highest pain score affected by the use of cryo nerve block? * Is there an effect on the lung function ? * Does cryo nerve block cause specific complications? * are patients treated with cryo nerve block still needing the same amount of morphine as a pain killer? * is the length of stay in intensive care influenced by the use of cryo nerve block? * and is the qualiy of life influenced by the use of cryo nerve block? Participants will: * undergo cryo nerve block or receive routine pain treatment after bilateral lung transplantation * be followed up during the first week after the operation, and every month to determine their pain * be asked to perform a lung function test and complete quality of life questionnaires 1, 2, 3, 6 months and 1 year after transplantation

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue pain Scale value

Timeframe: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative

Lung function

Timeframe: 1, 2, 3, 6 and 12 months postoperative

opioid consumption

Timeframe: postoperative days 1-7, and every monthly contact until 1 year postoperative

Length of stay (LOS) at ICU

Timeframe: from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative

Total hospital length of stay (HLOS)

Timeframe: from treatment until last day in the hospital of the index admission, between 2 days and 6 months postoperative

Evaluation of Quality of life - SF12

Timeframe: single time points at 1, 2, 3, 6 months and 1 year postoperative

Evaluation of Quality of life - EQ5D5L

Trial details

NCT IDNCT06959056

SponsorUniversity Hospital, Gasthuisberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Hans Van Veer, MD

+3216346822 hans.vanveer@uzleuven.be

View on ClinicalTrials.gov More Lung Transplant; Pain trials