Intercostal Cryoanalgesia in Double Lung Transplant Recipients

University of California, Los Angeles (UCLA)

Status: Not yet enrolling

Conditions: Post-operative Pain Management

Treatments: Device: Atricure CryoSPHERE MAX Probe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07281118

IRB-24-6029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Multi-organ transplant recipients
• Redo lung transplant recipients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

148 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2

Treatment:

Device: Atricure CryoSPHERE MAX Probe

Usual Care

No Intervention group

Description:

No treatment intra-operatively