Intercostal Cryoneurolysis Following Traumatic Rib Fractures

NCT03917823 | Terminated Results FDA Device

• 1 other identifier: Cryoneurolysis & Rib Fracture
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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 randomized, double-masked, sham-controlled study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Average Resting Pain Score

  Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

  Day following treatment

Secondary Outcomes (4)

• Average Pain Score

  Days 2-4, Weeks 1-3, Months 1,3,6

• Worst Pain Score

  Days 1-4, weeks 1-4, months 3 & 6

• Opioid Consumption

  Days 1-4, 7, 14, 21, and months 1, 3 and 6

• Incentive Spirometer Volume

  Days 1-4, 7, 14, and 21

Study Arms (2)

Cryoneurolysis (active)

EXPERIMENTAL

The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation (active or sham) separated by 1-minute defrost periods.

Device: Cryoneurolysis

Sham

SHAM COMPARATOR

For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.

Device: Sham comparator

Interventions

Cryoneurolysis DEVICE

The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.

Cryoneurolysis (active)

Sham comparator DEVICE

For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of at least 18 years of age
• having 1-3 sustained rib fractures on either or both sides (if bilateral fractures, then total up to 6 fractures with up to 3 per side)
• regional anesthetic requested by the admitting service
• accepting of a cryoneurolysis procedure

You may not qualify if:

• chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks
• pregnancy
• incarceration
• inability to communicate with the investigators
• morbid obesity (body mass index \> 40 kg/m2)
• possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
• any patient unable to correctly perform incentive spirometry as this is an outcome measure
• any patient with any degree of decreased mental capacity as determined by the surgical service
• any reason an investigator believes study participation would not be in the best interest of the potential subject, including an anti-coagulated state

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University of California San Diego

bilfeld@health.ucsd.edu

858-822-0776

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Cryoneurolysis probes are available for a console neurolysis device (PainBlocker, Epimed, Farmers Branch, Texas) that either (1) pass nitrous oxide to the tip inducing freezing temperatures; or, (2) vent the nitrous oxide at the base of the probe so that no gas reaches the probe tip, resulting in no temperature change. The latter is a sham procedure since without the temperature change, no ice ball forms and therefore the target nerve is not affected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Randomized, double-masked, sham-controlled, parallel-arm human subjects clinical trial

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 17, 2019
• Study Start: April 20, 2019
• Primary Completion: September 24, 2019
• Study Completion: March 25, 2020
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)