Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

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 Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Intrathoracic Procedure
• Intervention / Treatment: Procedure: Standard of Care; Device: Atricure's crysoSPHERE probe

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shari L Barnett; Phone Number: 734-936-4561; Email: shbailey@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Shari L Barnett; Phone Number: 734-936-4561; Email: shbailey@umich.edu
      • Principal Investigator: Rishindra Reddy, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intercostal nerve block; Standard of care	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.; Other Names: Intercostal nerve block
Experimental: Cryoablation; 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.	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.; Other Names: cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity 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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Quality of life score as measured by SF-36 Health questionnaire	36 item survey instrument	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)	Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.	Up to 180-days postop
Workflow/time	Including items such as length of operating room use and length of hospital stay	Up to 180-days postop

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications following surgery	Any unexpected or unanticipated incidents, symptoms or medical issues following surgery	Up to 180-days following surgery
Length of stay	length of hospital stay	Up to hospital discharge, approximately 3 days
Time to ambulation	Day of first ambulation documented	Up to 180-days following surgery
Chronic Pain medication use through 6 months		Up to 180-days after surgery
Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Intensity survey	Up to 180-days after surgery
Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Interference survey	Up to 180-days after surgery
Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Neuropathic Pain Quality Survey	Up to 180-days after surgery
Incentive spirometry volumes in the peri-operative period (POD 1 and 2)		Postop day 1 and 2
Oxygen requirement	documentation of oxygen use	Up to 180-days postop
Hospital charges and hospital reimbursement by different payors		Up to 180-days postop

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: AtriCure, Inc.
• Investigators: Principal Investigator: Rishindra Reddy, MD, MBA, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Health Services Administration; Health Care Quality, Access, and Evaluation; Surgical Procedures, Operative; Quality of Health Care; Quality Indicators, Health Care; Ablation Techniques; Standard of Care; Cryosurgery
• Other Study ID Numbers: HUM00241242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No