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NCT Number: NCT06959056

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

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

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Key information

Conditions

Lung Transplant; Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Celine Rihon, RN

CONTACT

[email protected]

+3216345857

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

cryo nerve block at T3-T8 intercostal nerves bilaterally

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Celine Rihon, RN

CONTACT

[email protected]

+3216345857

Hans Van Veer, MD

CONTACT

[email protected]

+3216346822

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study

Acronym: CRyoLTRiX

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 6, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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