RecruitingNot Applicable

Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

United States80 participantsStarted 2024-06-03

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severity of pain in the peri-operative period

Timeframe: Post-op day 1 and day of hospital discharge, approximately 3 days

Inflammatory cytokine levels as measured by blood samples

Timeframe: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery

Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score

Timeframe: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery

Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)

Timeframe: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop

Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)

Timeframe: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop

Trial details

NCT IDNCT06384664

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Shari L Barnett

734-936-4561 shbailey@umich.edu

View on ClinicalTrials.gov More Pain, Postoperative trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Severity of pain in the peri-operative period

Timeframe: Post-op day 1 and day of hospital discharge, approximately 3 days

Inflammatory cytokine levels as measured by blood samples

Timeframe: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery

Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score

Timeframe: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery

Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)

Timeframe: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop

Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)

Timeframe: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop