Clinical trial NCT06959056: Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation
Official title: Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Transplant; Pain
Keywords: cryo nerve block
lung transplantation
cryoanalgesia
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Visual Analogue pain Scale value
timeFrame: Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative
measure: Lung function
timeFrame: 1, 2, 3, 6 and 12 months postoperative
measure: opioid consumption
timeFrame: postoperative days 1-7, and every monthly contact until 1 year postoperative
measure: Length of stay (LOS) at ICU
timeFrame: from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative
measure: 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
measure: Evaluation of Quality of life - SF12
timeFrame: single time points at 1, 2, 3, 6 months and 1 year postoperative
measure: Evaluation of Quality of life - EQ5D5L
timeFrame: single time points at 1, 2, 3, 6 months and 1 year postoperative
measure: Evaluation of Quality of life - Brief Pain Inventory
timeFrame: single time points at 1, 2, 3, 6 months and 1 year postoperative
measure: Evaluation of Neuropathic Pain
timeFrame: single time points at 1, 2, 3, 6 months and 1 year postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Hans Van Veer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Laurens Ceulemans, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Yanina Jansen, MD, PhD
role: STUDY_CHAIR
References: