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

NCT ID: NCT06959056

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2027-12-31

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

Conditions

Lung Transplant; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cryo nerve block + routine pain care

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.

Group Type: ACTIVE_COMPARATOR

cryo nerve block at T3-T8 intercostal nerves bilaterally

Intervention Type: 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.

Routine pain care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cryo nerve block at T3-T8 intercostal nerves bilaterally

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gasthuisberg

OTHER

Sponsor Role: lead

Responsible Party

Hans Van Veer, MD

Consultant Thoracic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Van Veer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Laurens Ceulemans, MD, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Yanina Jansen, MD, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Hans Van Veer, MD

Role: CONTACT

hans.vanveer@uzleuven.be

+3216346822

Celine Rihon, RN

Role: CONTACT

celine.rihon@uzleuven.be

+3216345857

Facility Contacts

Celine Rihon, RN

Role: primary

celine.rihon@uzleuven.be

+3216345857

Other Identifiers

U1111-1320-5059

Identifier Type: OTHER

Identifier Source: secondary_id

S68933

Identifier Type: -

Identifier Source: org_study_id