Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- University of Michigan
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Rishindra Reddy
Research Professor of Thoracic Surgery
University of Michigan
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
Outcomes
Primary Outcomes
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
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
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
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
Secondary Outcomes
- Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)(Up to 180-days postop)
- Quality of life score as measured by SF-36 Health questionnaire(baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.)
- Workflow/time(Up to 180-days postop)