Intercostal Cryoanalgesia in Double Lung Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atricure CryoSPHERE MAX Probe.
- Who it may be relevant to
- Registry conditions: Post-operative Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Total opioid use (oral morphine equivalents) [Time frame: 1 year]
Secondary outcome measures (3)
- Frequency of rescue therapy [Time frame: 1 year]
- Median daily pain score [Time frame: Day 10]
- Duration of ICU Stay [Time frame: Days 1-10, 30 days, 60 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- University of California Los Angeles — Los Angeles
- University of California San Francisco — San Francisco
- Baylor University — Waco
Identifiers
NCT: NCT07281118 · IRB-24-6029