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

Not Applicable

Not yet recruiting

• Conditions: Lung Transplant; Pain

• Registration Number: NCT06959056
• Lead Sponsor: University Hospital, Gasthuisberg

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-27
• Last Update Submitted: 2025-04-27
• Study Start: 2025-05
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Quality of life - Brief Pain Inventory	single time points at 1, 2, 3, 6 months and 1 year postoperative	Evaluation of quality of life by completion of standardized Quality of Life questionnaire (Brief Pain Inventory); lower score equals better quality of life
Visual Analogue pain Scale value	Postoperative days 0 to 7, 14, and 21 and every month postoperative until 1 year postoperative	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.
Lung function	1, 2, 3, 6 and 12 months postoperative	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.
opioid consumption	postoperative days 1-7, and every monthly contact until 1 year postoperative	use of iv or oral morphin derivatives including tramadol, as well as transdermal delivery forms, expressed in oral morphine milligram equivalents (OMME)
Length of stay (LOS) at ICU	from transplantation until actual discharge of the intensive care unit, between 2 days and 6 months postoperative	length of stay at the intensive care unit, expressed in days
Total hospital length of stay (HLOS)	from treatment until last day in the hospital of the index admission, between 2 days and 6 months postoperative	total length of hospital stay, expressed in days
Evaluation of Quality of life - SF12	single time points at 1, 2, 3, 6 months and 1 year postoperative	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
Evaluation of Quality of life - EQ5D5L	single time points at 1, 2, 3, 6 months and 1 year postoperative	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
Evaluation of Neuropathic Pain	single time points at 1, 2, 3, 6 months and 1 year postoperative	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

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium