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Intercostal Cryoneurolysis Following Traumatic Rib Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917823
Recruitment Status : Terminated (Revised protocol to such a significant degree that we simply closed this study and started a new study.)
First Posted : April 17, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Rib Fractures Device: Cryoneurolysis Device: Sham comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-masked, sham-controlled, parallel-arm human subjects clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intercostal Cryoneurolysis Following Traumatic Rib Fractures
Actual Study Start Date : April 20, 2019
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoneurolysis (active)
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
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.

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




Primary Outcome Measures :
  1. Average Resting Pain Score [ Time Frame: Day following treatment ]
    Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain


Secondary Outcome Measures :
  1. Average Pain Score [ Time Frame: Days 1-4 ]
    Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

  2. Worst Pain Score [ Time Frame: Days 1-4 ]
    Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

  3. Lowest Pain Score [ Time Frame: Days 1-4 ]
    Pain score measured using the numeric rating scale for pain: 0=no pain and 10=worst imaginable pain

  4. Current Pain Score [ Time Frame: Days 0-4 ]
    Pain score measured using the numeric rating scale for pain

  5. Opioid consumption [ Time Frame: Days 0-4, 7, 14, 21, and months 1, 3 and 6 ]
    Number of opioid tablets consumed previous 24 hours (oxycodone 5 mg)

  6. Sleep disturbances [ Time Frame: Days 1-4, 7, 14, 21, and 28 ]
    Number of sleep disturbances due to pain

  7. Incentive Spirometer Volume [ Time Frame: Days 0-4, 7, 14, 21, and 28 ]
    maximum incentive spirometer volume

  8. Pain level and interference [ Time Frame: Days 7, 14, 21, 28, and Months 3 and 6 ]
    Measured using the Brief Pain Inventory (BPI) which, in addition to pain intensity scales (of 0-10, 0=no pain and 10=worst imaginable) includes seven measures evaluating pain's interference with physical and emotional functioning, such as sleep, relations with others, and enjoyment of life (0-10 scale, 0=no interference and 10=worst imaginable interference). Subscales for both pain scores and the interference scores will be reported along with total scores and scores for each individual question.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917823


Locations
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United States, California
University California San Diego
San Diego, California, United States, 92130
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03917823    
Other Study ID Numbers: Cryoneurolysis & Rib Fracture
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries