Lung Transplant; PainCRyoLTRiXNCT06959056
Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation
A study testing cryo nerve block at T3-T8 intercostal nerves bilaterally in people with Lung Transplant; Pain, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Pain
- What is being tested?
- cryo nerve block at T3-T8 intercostal nerves bilaterally
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Celine Rihon, RN, +3216345857, celine.rihon@uzleuven.be
About this study
Official title: Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study
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:
Read more
- 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
- Conditions
- Lung Transplant; Pain
- Being tested
- cryo nerve block at T3-T8 intercostal nerves bilaterally
- Keywords
- cryo nerve block, lung transplantation, cryoanalgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryo nerve block at T3-T8 intercostal nerves bilaterallyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryo nerve block + routine pain care | Active comparator | 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. Receives: Device: cryo nerve block at T3-T8 intercostal nerves bilaterally |
| Routine pain care | No intervention | Participants in the control arm will receive standard institutional pain care following bilateral lungtransplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative
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.
Measured: 1, 2, 3, 6 and 12 months postoperative
opioid consumption
use of iv or oral morphin derivatives including tramadol, as well as transdermal delivery forms, expressed in oral morphine milligram equivalents (OMME)
Measured: postoperative days 1-7, and every monthly contact until 1 year postoperative
Length of stay (LOS) at ICU
length of stay at the intensive care unit, expressed in days
Measured: from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative
Total hospital length of stay (HLOS)
total length of hospital stay, expressed in days
Measured: 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
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
Measured: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Measured: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Measured: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Measured: single time points at 1, 2, 3, 6 months and 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start4 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Van Veer, MD, University Hospital, Gasthuisberg
- Investigators
- Hans Van Veer, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenLaurens Ceulemans, MD, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenYanina Jansen, MD, PhD, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959056
- Sponsor's protocol ID
- S68933
- Other IDs
- U1111-1320-5059
- Acronym
- CRyoLTRiX
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data embargo imposed by the research institution
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study
- ClinicalTrials.gov ID
- NCT06959056
- Acronym / sponsor ID
- CRyoLTRiX / S68933
- Conditions
- Lung Transplant; Pain
- Keywords
- cryo nerve block, lung transplantation, cryoanalgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo nerve block + routine pain care | Active comparator | Device: cryo nerve block at T3-T8 intercostal nerves bilaterallyParticipants 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. |
| Routine pain care | No intervention | –Participants in the control arm will receive standard institutional pain care following bilateral lungtransplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Unilateral lung transplantation
- Lobar transplantation
- Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
- Combined organ transplantation
- Chronic opioid use pre-operatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryo nerve block at T3-T8 intercostal nerves bilaterallyIn 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. | Device | Cryo nerve block + routine pain care |
Primary outcome
Visual Analogue pain Scale value
Time frame: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative
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.
Lung function
Time frame: 1, 2, 3, 6 and 12 months postoperative
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.
opioid consumption
Time frame: postoperative days 1-7, and every monthly contact until 1 year postoperative
use of iv or oral morphin derivatives including tramadol, as well as transdermal delivery forms, expressed in oral morphine milligram equivalents (OMME)
Length of stay (LOS) at ICU
Time frame: from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative
length of stay at the intensive care unit, expressed in days
Total hospital length of stay (HLOS)
Time frame: from treatment until last day in the hospital of the index admission, between 2 days and 6 months postoperative
total length of hospital stay, expressed in days
Evaluation of Quality of life - SF12
Time frame: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Evaluation of Quality of life - EQ5D5L
Time frame: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Evaluation of Quality of life - Brief Pain Inventory
Time frame: single time points at 1, 2, 3, 6 months and 1 year postoperative
Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Brief Pain Inventory); lower score equals better quality of life
Evaluation of Neuropathic Pain
Time frame: single time points at 1, 2, 3, 6 months and 1 year postoperative
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. Data embargo imposed by the research institution
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryo nerve block at T3-T8 intercostal nerves bilaterally in people with Lung Transplant; Pain, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Van Veer, MD (+3216346822, hans.vanveer@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue pain Scale value (time frame: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.