Recruiting NCT06384664
Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
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's crysoSPHERE probe, Standard of Care.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Intrathoracic Procedure. 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 →
Unsure about the terms? Read our patient guide →
Overview
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]
- Inflammatory cytokine levels as measured by blood samples [Time frame: 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 [Time frame: 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) [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]
- 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]
Secondary outcome measures (3)
- Quality of life score as measured by SF-36 Health questionnaire [Time frame: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.]
- Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) [Time frame: Up to 180-days postop]
- Workflow/time [Time frame: Up to 180-days postop]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06384664 · HUM00241242