Rib Fracture Analgesia Using Cryoanalgesia

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 3, 2020

Primary Completion Date

August 28, 2023

Study Completion Date

August 27, 2024

Conditions
Traumatic Rib Fracture(s)
Interventions
DEVICE

Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)

The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.

DRUG

Intercostal nerve block ropivacaine with epinephrine

3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)

DEVICE

Sham cryoneurolysis with a Painblocker

The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.

DRUG

Placebo intercostal nerve block with normal saline

3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks

Trial Locations (1)

92103

University California San Diego, San Diego

All Listed Sponsors
lead

University of California, San Diego

OTHER

NCT04198662 - Rib Fracture Analgesia Using Cryoanalgesia | Biotech Hunter | Biotech Hunter