Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-01 @ 10:09 AM
Study NCT ID:
NCT06959056
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation
Sponsor:
University Hospital, Gasthuisberg
Organization:
Study Overview
Official Title:
Evaluating the Impact of Cryo-analgesia on Recovery After Double Lung Transplantation: a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRyoLTRiX
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1320-5059 | OTHER | WHO | View |