Cryoanalgesia Study

Northwestern University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe

Study type: Interventional

Funder types: Other

Identifiers

NCT05859061

STU00218457

Details and patient eligibility

About

This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
• Reasonable expectation to be extubated within 24 hours postop

Exclusion criteria

• Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
• Hemisternotomy approach
• History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
• Preoperative use of opioids
• History of chronic pain or associated syndromes
• Concurrent Cox maze procedure
• Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest
• Women who are pregnant or breastfeeding
• Patients who are unable to consent for themselves

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Cryoanalgesia

Experimental group

Description:

Intraoperative analgesic administration will be at the discretion of the anesthesia provider. Once adequate hemostasis is achieved and prior to sternal wire placement and chest closure, patients will undergo cryoablation of bilateral T2 - T6 intercostal nerves. The cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. Each cryoablation at -50°C to -70°C will be applied for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6).

Treatment:

Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe

Standard of Care (Control)

No Intervention group

Description:

Patients in this arm will receive standard of care pain management alone.