Post-operative Pain Management
Conditions
Keywords
Lung Transplant, Pain Management
Brief 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.
Interventions
DEVICEAtricure 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.
Sponsors
University of California, Los Angeles
AtriCure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid use (oral morphine equivalents) | 1 year | Total opioid use (oral morphine equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of rescue therapy | 1 year | Compare need for thoracic epidural anesthesia. |
| Median daily pain score | Day 10 | 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. |
| Duration of ICU Stay | Days 1-10, 30 days, 60 days | To compare the duration of the ICU stay |
Countries
United States
Contacts
CONTACTSteven Stokes
CONTACTJenny Lester, MPH
PRINCIPAL_INVESTIGATORAbbas Ardehali, MD
University of California, Los Angeles
Outcome results
None listed