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Cryoablation for Pain After Thoracic Surgery

This study is looking at how well a procedure called cryoablation (freezing tissue with a device called a cryoSPHERE probe) works to control pain after chest surgery (thoracotomy or thoracoscopy). Researchers will compare cryoablation to the standard pain relief method, which is an intercostal nerve block (injecting numbing medicine around nerves). They want to see if cryoablation offers better pain control right after surgery and if it affects inflammation. You might be able to join if you are 18 or older, having certain chest surgeries at Michigan Medicine, and haven't used opioids before. The study aims to enroll 80 people.

Study design
This interventional study plans to enroll 80 participants. It compares two different pain control methods after chest surgery.
What's involved
You would have blood samples taken before surgery, and then 6 and 24 hours after surgery. Pain levels will be measured on post-operative day 1 and the day you leave the hospital.
Compensation
Not stated in the trial record.
Follow-up
Pain levels will be assessed for approximately 3 days after surgery, and blood samples will be taken up to 24 hours after surgery.

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NCT06384664

Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Recruiting
NAAges 18+InterventionalSupportive care
University of Michigan
~80 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Atricure's crysoSPHERE probeStandard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Severity of pain in the peri-operative period
Measured over Post-op day 1 and day of hospital discharge, approximately 3 days
+4 more outcomes measured

Conditions

Pain, Postoperative
Intrathoracic Procedure

Explore related trials

Post-Operative Pain

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Rishindra Reddy, MD, MBA · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Shari L Barnett
[email protected]
734-936-4561
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Severity of pain in the peri-operative periodPost-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 samplesPre-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 scorePre-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)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)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