NCT07281118

Intercostal Cryoanalgesia in Double Lung Transplant Recipients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Post-operative Pain Management

Interventions

Type	Name	Description
DEVICE	Atricure CryoSPHERE MAX Probe	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.

Timeline

• Start date: 2025-12-16
• Primary completion: 2027-11-24
• Completion: 2027-11-24
• First posted: 2025-12-15
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study