Intercostal Cryoanalgesia in Double Lung Transplant Recipients

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain Management
• Intervention / Treatment: Device: Atricure CryoSPHERE MAX Probe

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.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Lester, MPH; Phone Number: 310-794-9728; Email: jlester@mednet.ucla.edu
• Study Contact Backup: Name: Steven Stokes; Phone Number: 310-206-7436; Email: sstokes@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Principal Investigator: Abbas Ardehali, MD
      • Contact: Jenny Lester, MPH; Phone Number: 310-794-9728; Email: jlester@mednet.ucla.edu
      • Contact: Steven Stokes; Phone Number: 310-794-206-7436; Email: sstokes@mednet.ucla.edu
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • University of California San Francisco
  • Texas
    • Waco, Texas, United States, 76706
      • Not yet recruiting
      • Baylor University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2	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.; Other Names: Cryotherapy
No Intervention: Usual Care; No treatment intra-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid use (oral morphine equivalents)	Total opioid use (oral morphine equivalents)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of rescue therapy	Compare need for thoracic epidural anesthesia.	1 year
Median daily pain score	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.	Day 10
Duration of ICU Stay	To compare the duration of the ICU stay	Days 1-10, 30 days, 60 days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: AtriCure, Inc.
• Investigators: Principal Investigator: Abbas Ardehali, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 24, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain Management; Lung Transplant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Therapeutics; Cryotherapy
• Other Study ID Numbers: IRB-24-6029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary data and results will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No