NCT06384664 · University of Michigan
Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
What this study is about
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
View original scientific description
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
Interventions
DEVICE
Atricure's crysoSPHERE probe
Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.
PROCEDURE
Standard of Care
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.
Primary outcome measures
Severity of pain in the peri-operative period
Time frame: Post-op day 1 and day of hospital discharge, approximately 3 days
Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity
Inflammatory cytokine levels as measured by blood samples
Time frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a
Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score
Time frame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Correlations with the pain scores from outcome #1
Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
Time frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys
Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
Time frame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
- Patient is opioid naïve
Exclusion criteria
- Patients who are pregnant
- Patients with cognitive impairment
- Patients with psychological disorders
- Patients with prior thoracic surgery
- Patients with fibromyalgia
- Patients with redo ipsilateral thoracic surgery
- Patients undergoing bilateral thoracotomy
Where
- Ann Arbor, Michigan
Collaborators
AtriCure, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2025 · Source of record for eligibility and locations