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

NCT06959056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University Hospital, Gasthuisberg

    lead OTHER

Principal Investigators

  • Hans Van Veer, MD · Universitaire Ziekenhuizen KU Leuven

  • Laurens Ceulemans, MD, PhD · Universitaire Ziekenhuizen KU Leuven

  • Yanina Jansen, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2026-05-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959056 on ClinicalTrials.gov