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NCT Number: NCT06384664

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Rishindra Reddy, MD, MBA

PRINCIPAL_INVESTIGATOR

Shari L Barnett

CONTACT

[email protected]

734-936-4561

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: Intercostal nerve block

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Quality of life score as measured by SF-36 Health questionnaire

    Time frame: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.

    36 item survey instrument

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

    Time frame: Up to 180-days postop

    Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.

  3. Workflow/time

    Time frame: Up to 180-days postop

    Including items such as length of operating room use and length of hospital stay

Other outcomes

  1. Complications following surgery

    Time frame: Up to 180-days following surgery

    Any unexpected or unanticipated incidents, symptoms or medical issues following surgery

  2. Length of stay

    Time frame: Up to hospital discharge, approximately 3 days

    length of hospital stay

  3. Time to ambulation

    Time frame: Up to 180-days following surgery

    Day of first ambulation documented

  4. Chronic Pain medication use through 6 months

    Time frame: Up to 180-days after surgery

  5. Chronic pain through 6 months.

    Time frame: Up to 180-days after surgery

    Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Intensity survey

  6. Chronic pain through 6 months.

    Time frame: Up to 180-days after surgery

    Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Interference survey

  7. Chronic pain through 6 months.

    Time frame: Up to 180-days after surgery

    Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Neuropathic Pain Quality Survey

  8. Incentive spirometry volumes in the peri-operative period (POD 1 and 2)

    Time frame: Postop day 1 and 2

  9. Oxygen requirement

    Time frame: Up to 180-days postop

    documentation of oxygen use

  10. Hospital charges and hospital reimbursement by different payors

    Time frame: Up to 180-days postop

Study contacts

Contact information is provided by the study sponsor or research team.

Shari L Barnett

CONTACT

[email protected]

734-936-4561

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • AtriCure, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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