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

University Hospital, Gasthuisberg

Status: Not yet enrolling

Conditions: Lung Transplant; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06959056

U1111-1320-5059 (Other Identifier)

S68933

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Cryo nerve block + routine pain care

Active Comparator group

Description:

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.

Treatment:

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

Routine pain care

No Intervention group

Description:

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