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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1320-5059 | Other Identifier | WHO |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Routine pain care | No Intervention | Participants in the control arm will receive standard institutional pain care following bilateral lungtransplantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Van Veer, MD | Contact | +3216346822 | hans.vanveer@uzleuven.be | |
| Celine Rihon, RN | Contact | +3216345857 | celine.rihon@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Hans Van Veer, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Laurens Ceulemans, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
Data embargo imposed by the research institution
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Yanina Jansen, MD, PhD |
| Universitaire Ziekenhuizen KU Leuven |
| Study Chair |