Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Not Applicable

Recruiting

• Conditions: Pain, Postoperative; Intrathoracic Procedure
• Interventions: Device: Atricure's crysoSPHERE probe; Procedure: Standard of Care

• Registration Number: NCT06384664
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Status Verified: 2024-06
• Study Start: 2024-06-03
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2027-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	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.
Intercostal nerve block	Standard of Care	Standard of care

Primary Outcome Measures

Name	Time	Method
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
Severity of pain in the peri-operative period	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)	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	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	Pre-surgery, 6-hours after end of surgery and 24-hours after surgery	Correlations with the pain scores from outcome #1

Secondary Outcome Measures

Name	Time	Method
Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)	Up to 180-days postop	Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.
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.	36 item survey instrument
Workflow/time	Up to 180-days postop	Including items such as length of operating room use and length of hospital stay

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States