NCT Number: NCT07281118
This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like opioids, doctors will use a cold-therapy probe during surgery to help numb the nerves near the incision. Researchers want to see if this method can reduce the need for opioids and improve recovery.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of California Los Angeles, Los Angeles, California, United States
This study is being done to learn whether a special cold-therapy treatment can help control pain after a double lung transplant. During the surgery, doctors may use a device called the Atricure CryoSPHERE MAX Probe, which gently freezes the nerves around the incision to reduce pain for several days. This freezing effect may help patients need fewer opioid pain medicines, which can sometimes cause sleepiness or make it harder to breathe deeply after surgery. Researchers will compare patients who receive the cryotherapy treatment to patients who receive the usual care without the device.
The main goal is to see whether the cryotherapy group uses at least 25% fewer opioids in the first 10 days after surgery. The study will also look at how often patients still need extra pain treatments, such as an epidural, and whether their average daily pain scores are lower. Another important question is whether the treatment can help shorten the amount of time patients need to stay in the ICU. About 148 people from several hospitals will take part in the study. Everyone who joins the study will be followed for one year after their transplant to monitor their recovery and any long-term effects of the treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2 intercostal spaces above and below the thoracotomy incision for 1 minutes for each application during their double lung transplant procedure.
Other names: Cryotherapy
Time frame: 1 year
Total opioid use (oral morphine equivalents)
Time frame: 1 year
Compare need for thoracic epidural anesthesia.
Time frame: Day 10
To compare the Median daily pain score for the first 10 days after lung transplantation, Numerical Rating Scale (NRS) (0-10): A standard 11-point scale (0=no pain, 10=worst imaginable pain) used for pain intensity, showing good reliability and validity in various conditions like neuropathic pain.
Time frame: Days 1-10, 30 days, 60 days
To compare the duration of the ICU stay
Contact information is provided by the study sponsor or research team.
Jenny Lester, MPH
CONTACT
Steven Stokes
CONTACT
University of California, Los Angeles
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07577908
Intercostal Nerve Block, Post-operative Pain Management
İzmit, Turkey (Türkiye)
View Trial DetailsNCT07095556
Inflammation, Mouth Diseases
Charleston, South Carolina, United States
View Trial DetailsNCT06843174
Post-operative Care, Post-operative Pain Management
Toronto, Ontario, Canada
View Trial DetailsNCT07250373
Intercostal Nerve Block, Locoregional Anesthesia
Rome, Lazio, Italy
View Trial Details