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

NCT06959056 | Recruiting FDA Device

• 2 other identifiers: S68933U1111-1320-5059
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

cryo nerve block; lung transplantation; cryoanalgesia

Outcome Measures

Primary Outcomes (9)

• Visual Analogue pain Scale value

  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.

  Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative

• Lung function

  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.

  1, 2, 3, 6 and 12 months postoperative

• opioid consumption

  use of iv or oral morphin derivatives including tramadol, as well as transdermal delivery forms, expressed in oral morphine milligram equivalents (OMME)

  postoperative days 1-7, and every monthly contact until 1 year postoperative

• Length of stay (LOS) at ICU

  length of stay at the intensive care unit, expressed in days

  from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative

• Total hospital length of stay (HLOS)

  total length of hospital stay, expressed in days

  from treatment until last day in the hospital of the index admission, between 2 days and 6 months postoperative

• Evaluation of Quality of life - SF12

  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

  single time points at 1, 2, 3, 6 months and 1 year postoperative

• Evaluation of Quality of life - EQ5D5L

  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

  single time points at 1, 2, 3, 6 months and 1 year postoperative

• Evaluation of Quality of life - Brief Pain Inventory

  Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Brief Pain Inventory); lower score equals better quality of life

  single time points at 1, 2, 3, 6 months and 1 year postoperative

• Evaluation of Neuropathic Pain

  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

  single time points at 1, 2, 3, 6 months and 1 year postoperative

Study Arms (2)

Cryo nerve block + routine pain care

ACTIVE COMPARATOR

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.

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

Routine pain care

NO INTERVENTION

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

Interventions

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.

Cryo nerve block + routine pain care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Van Veer, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Laurens Ceulemans, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY CHAIR

• Yanina Jansen, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY CHAIR

Central Study Contacts

Hans Van Veer, MD

CONTACT

+3216346822; hans.vanveer@uzleuven.be

Celine Rihon, RN

CONTACT

+3216345857; celine.rihon@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Thoracic Surgeon

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 6, 2025
• Study Start: December 3, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)