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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
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.
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGSeverity of pain in the peri-operative period
Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity
Time frame: Post-op day 1 and day of hospital discharge, approximately 3 days
Inflammatory cytokine levels as measured by blood samples
Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a
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
Correlations with the pain scores from outcome #1
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)
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys
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)
assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment
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
Quality of life score as measured by SF-36 Health questionnaire
36 item survey instrument
Time frame: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.
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Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)
Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.
Time frame: Up to 180-days postop
Workflow/time
Including items such as length of operating room use and length of hospital stay
Time frame: Up to 180-days postop