UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 23, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Rib FracturesRib Fracture MultipleRib; Fracture, With Flail ChestPainPain, AcutePain, ChronicTraumaTrauma Injury
Interventions
PROCEDURE

Cryoneurolysis

Cryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

PROCEDURE

Sham Cryoneurolysis

Participants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

Trial Locations (1)

M4N3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER