Cryo-freezing of chest nerves to reduce pain after double lung transplant
Intercostal Cryoanalgesia in Double Lung Transplant Recipients
This tests whether freezing the nerves around the chest incision during double lung transplant helps adults need fewer opioid pain medicines and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT07281118 on ClinicalTrials.gov |
What this trial studies
During double lung transplant surgery, surgeons may use a cold-therapy probe (Atricure CryoSPHERE MAX) to gently freeze the intercostal nerves near the incision to reduce pain for several days. Patients who receive intraoperative cryoanalgesia will be compared with patients receiving usual care without the device across several hospitals, with about 148 adults expected to enroll. The main goal is to see whether the cryotherapy group uses at least 25% fewer opioids in the first 10 days after surgery, and secondary outcomes include need for additional pain treatments like epidurals, average daily pain scores, and ICU length of stay. All participants will be followed for one year to monitor recovery and any long-term effects.
Who should consider this trial
Good fit: Adults (age ≥18) undergoing double lung transplantation via bilateral thoracotomies or a clamshell incision who are not receiving multi-organ or redo lung transplants.
Not a fit: Patients undergoing single lung transplant, multi-organ transplants, redo lung transplants, or those treated outside the participating centers are not eligible and therefore unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the technique could cut opioid needs after transplant, improve breathing and alertness, and potentially shorten ICU stays.
How similar studies have performed: Intercostal cryoanalgesia has shown promising reductions in pain and opioid use in other thoracic surgeries, but data are limited specifically for double lung transplant patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 2 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- Baylor University — Waco, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Abbas Ardehali, MD — University of California, Los Angeles
- Study coordinator: Steven Stokes
- Email: sstokes@mednet.ucla.edu
- Phone: 310-206-7436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.