About this trial
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
Qualifiers
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)
Disqualifiers
Unilateral lung transplantation
Lobar transplantation
Donor lung reconditioning using ex-vivo lung perfusion (EVLP)
Combined organ transplantation
Trial design
Treatments tested in this trial
- cryo nerve block at T3-T8 intercostal nerves bilaterally