Rib Fracture Analgesia Using Cryoanalgesia

Summary

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this multicenter, randomized, double-masked, sham-controlled, parallel-arm study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.

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

Sponsors & Collaborators

• University of California, San Diego

  lead OTHER

Principal Investigators

• Brian M Ilfeld, MD, MS · University California San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-03

Primary Completion

2023-08-28

Completion

2024-08-27

FDA Device

Yes

Countries

• United States

Study Locations