NCT05415384

Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Detailed description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Conditions

• Pain, Postoperative
• Rib Fracture Multiple

Interventions

Type	Name	Description
DEVICE	Cryoablation of Intercostal Nerves	Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
PROCEDURE	Standard surgical treatment of patients with multiple rib fractures	Standard surgical treatment of patients with multiple rib fractures

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2022-06-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study