NCT05859061

Cryoanalgesia Study

Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe	Per manufacturer instructions, 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. The study team plans to perform each cryoablation (-50°C to -70°C) for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). The probe will be removed after defrosting to avoid mechanical damage to the intercostal nerve. Cryoablation will be performed once hemostasis is achieved and prior to sternal wire placement and chest closure by a provider from the cardiac surgery team.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-07-20
• Completion: 2025-02-13
• First posted: 2023-05-15
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study