Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

University of Michigan

Status: Enrolling

Conditions: Intrathoracic Procedure; Pain, Postoperative

Treatments: Device: Atricure's crysoSPHERE probe; Procedure: Standard of Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06384664

HUM00241242

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intercostal nerve block

Active Comparator group

Description:

Standard of care

Treatment:

Procedure: Standard of Care

Cryoablation

Experimental group

Description:

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.

Treatment:

Device: Atricure's crysoSPHERE probe