ClinicalTrials.gg
RecruitingNCT06959056CRyoLTRiXUpdated Jun 5, 2026

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

An interventional study of cryo nerve block at T3-T8 intercostal nerves bilaterally in Lung Transplant; Pain, sponsored by University Hospital, Gasthuisberg. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University Hospital, Gasthuisberg · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 150 studies in Pain with a site in Belgium — 24 open to participants now, 26 under way, none of them phase 3. Pain · Belgium.

Planned enrollment
79th of 115
40 · median 64
Started
2026
with 5 others
No phase
63 of 150
15 open now
Primary completion
2026-12
later than 11 of 25 live
Registered
137th of 150
by date
Lead sponsor
4 of 150
University Hospital, Gasthuisberg

Among the 150 studies in Pain with a site in Belgium, this one is the 79th largest by planned enrollment of the 115 interventional ones that give a count, is one of 6 that started in 2026, is one of 63 with no phase, reaches primary completion later than 11 of the 25 other live ones, and was the 137th registered.

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

Browse Pain studies →

Open to participants now

24 of the 150 studies in Pain with a site in Belgium are open now. Recruiting first, the newest first:

18 more — sign in →

All 24 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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
03

Conditions studied

  • Lung Transplant; Pain

Browse trials for

Keywords

  • cryo nerve block
  • lung transplantation
  • cryoanalgesia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntary written 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 (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 for participation in the study.

Exclusion criteria

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 medicinal product (IMP) or device (IMD) that could potentially influence the post-operative outcomes of this study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Cryo nerve block + routine pain care

    Participants will undergo cryo nerve block at 6 levels of intercostal muscles, on each side from T3 to T8, 3cm lateral to the parasympathetic chain. The intervention will be performed after receptor pneumonectomy on each side.

    Device: cryo nerve block at T3-T8 intercostal nerves bilaterally

  • No intervention
    Routine pain care

    Participants in the control arm will receive standard institutional pain care following bilateral lungtransplantation.

Interventions

  • Devicecryo nerve block at T3-T8 intercostal nerves bilaterally

    In order to obtain better analgesia at the level of the chest wall, where the chest is bilaterally opened for lung extraction and donor lung implantation, intraoperative cryo-ablation will be applied to the intercostal nerves at the bilateral intercostal spaces 3-8, 3cm lateral to the sympathetic chain, under direct visualization during surgery, as such covering 2 intercostal levels above as well as below the normal access of ICR 4 or 5. By providing analgesia to level 8, we will also cover the area of chest drains, which also tend to cause pain in the postoperative course, especially when patients start mobilizing at the ward. Each nerve bundle will be cooled to a temperature between -65 and -72 °C during 120 seconds by means of the CyroSphere v2 probe (AtriCure Inc; Mason, OH, USA) connected to the provided instrument tower (AtriCure CryoICE box) including a processor device measuring and regulating the N2O flow through the probe.

06

What researchers measure

Primary outcomes

  1. Visual Analogue pain Scale value

    The highest pain score throughout the day in a participant, expressed on a Visual Analogue Scale instrument for assessing pain will be recorded. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

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

  2. Lung function

    Lung function evaluated by spirometry, recorded as Forced Expiratory Value at one second and Functional Vital Capacity expressed in liters and percentage of the expected.

    Time frame: 1, 2, 3, 6 and 12 months postoperative

  3. opioid consumption

    use of iv or oral morphin derivatives including tramadol, as well as transdermal delivery forms, expressed in oral morphine milligram equivalents (OMME)

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

  4. Length of stay (LOS) at ICU

    length of stay at the intensive care unit, expressed in days

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

  5. Total hospital length of stay (HLOS)

    total length of hospital stay, expressed in days

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

  6. Evaluation of Quality of life - SF12

    Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Short Form -12 (SF12)); 5 point likert scale; higher score equals better quality of life

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

  7. Evaluation of Quality of life - EQ5D5L

    Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Evaluation of Quality of Life in 5 domains at 5 levels (EQ5D5L)); minimum score 5, maximum score 25; lower score equals better quality of life

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

  8. Evaluation of Quality of life - Brief Pain Inventory

    Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Brief Pain Inventory); lower score equals better quality of life

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

  9. Evaluation of Neuropathic Pain

    Evaluation of pain characteristics in order to probe for neuropathic pain levels by means of the Neuropathic Pain Assessment questionnaire; 5 point likert scale, higher score is worse

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data embargo imposed by the research institution

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 11 months is close to that.

Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2025
First posted
May 6, 2025
StartActual
Jan 4, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 2027
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06959056
Lead sponsor
University Hospital, Gasthuisberg
Responsible party
Hans Van Veer, MD (Consultant Thoracic Surgeon, University Hospital, Gasthuisberg) — Principal investigator
First posted
May 6, 2025
Start date
Jan 4, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

Hans Van Veer, MD
Contact
hans.vanveer@uzleuven.be
+3216346822
Celine Rihon, RN
Contact
celine.rihon@uzleuven.be
+3216345857
Hans Van Veer, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Laurens Ceulemans, MD, PhD
study chair · Universitaire Ziekenhuizen KU Leuven
Yanina Jansen, MD, PhD
study chair · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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