Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Abbas Ardehali, MD (ucla)

Description

Summary

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.

Details

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.

Keywords

Post-operative Pain Management, Lung Transplant, Pain Management, Agnosia, Cryotherapy, Atricure CryoSPHERE MAX Probe

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adults ≥18 years of age
  • Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision

You CAN'T join if...

  • Multi-organ transplant recipients
  • Redo lung transplant recipients

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Baylor University
    Waco Texas 76706 United States

Lead Scientist at University of California Health

  • Abbas Ardehali, MD (ucla)
    Dr. Abbas Ardehali holds the William E. Connor Chair in Cardiothoracic Transplantation.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07281118
Study Type
Interventional
Participants
Expecting 148 study participants
Last Updated