Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

NCT06384664 | Recruiting FDA Device

• 1 other identifier: HUM00241242
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Intrathoracic Procedure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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.

• Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)

  Up to 180-days postop

• Workflow/time

  Up to 180-days postop

Other Outcomes (10)

• Complications following surgery

  Up to 180-days following surgery

• Length of stay

  Up to hospital discharge, approximately 3 days

• Time to ambulation

  Up to 180-days following surgery

Study Arms (2)

Intercostal nerve block

ACTIVE COMPARATOR

Standard of care

Procedure: Standard of Care

Cryoablation

EXPERIMENTAL

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

Interventions

Atricure's crysoSPHERE probe DEVICE

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.

Also known as: cryoablation

Cryoablation

Standard of Care PROCEDURE

An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Also known as: Intercostal nerve block

Intercostal nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• AtriCure, Inc.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryosurgery; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rishindra Reddy, MD, MBA

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari L Barnett

CONTACT

734-936-4561; shbailey@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Thoracic Surgery

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 25, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)