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Rib Fracture Analgesia Using Cryoanalgesia

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: NCT04198662
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2019
Last Update Posted : March 9, 2021
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 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.

Condition or disease Intervention/treatment Phase
Traumatic Rib Fracture(s) Device: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas) Drug: Intercostal nerve block ropivacaine with epinephrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, double-masked, sham-controlled, parallel design, clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The randomization lists will be created by the UC San Diego Investigational Drug Service which will create the sealed, opaque randomization envelopes with treatment group assignments. The treating investigators doing the procedures will be the only other individuals aware of the treatment group assignments. The Investigational Drug Service will not provide the treatment group assignments to the investigators until the completion of data collection for all subjects; and will only provide "Treatment A" vs "Treatment B" assignments for the initial statistical analysis. Only at the completion of statistical analysis will each treatment be revealed to the investigators.
Primary Purpose: Treatment
Official Title: Intercostal Cryoneurolysis Following Traumatic Rib Fractures
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : April 3, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Active Comparator: Cryoneurolysis
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Device: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)
The application of exceptionally low temperatures to reversibly ablate peripheral nerves, resulting in Wallerian degeneration with nerve regrowth at approximately 1-2 mm/day.
Other Name: Cryoanalgesia with a Painblocker (Epimed International, Farmers Branch, Texas)

Sham Comparator: Sham
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
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)
Other Name: peripheral nerve block




Primary Outcome Measures :
  1. maximum inspired volume [ Time Frame: Day 1 of study treatment ]
    maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.[Restrepo. Respirated Care 2011] The best of three measurements will be recorded as the maximum inspired volume.


Secondary Outcome Measures :
  1. maximum inspired volume [ Time Frame: Days 0, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12 ]
    maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.[Restrepo. Respirated Care 2011] The best of three measurements will be recorded as the maximum inspired volume.

  2. Spirometry pain [ Time Frame: Days 0, 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12 ]
    Worst pain level during the same-day spirometry use as measured using the 11-point Numeric Rating Scale with 0= no pain and 10= worst imaginable pain.

  3. Brief Pain Inventory [partial] [ Time Frame: Days 0, 1, 2, and 7 ]
    This instrument measures pain and pain's interference with 7 physical and emotional items; however, for these 4 time points, only the 4 questions regarding pain level will be recorded

  4. Brief Pain Inventory [ Time Frame: Day 14; Months 1, 1.5, 2, 3, 6, and 12 ]
    This instrument measures pain and pain's interference with 7 physical and emotional items

  5. Sleep disturbances due to pain [ Time Frame: Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12 ]
    Recorded as the number of awakenings subject-identified as due to pain during the previous evening

  6. Oral opioid consumption [ Time Frame: Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12 ]
    Recorded as the amount of oral oxycodone-equivalent analgesics consumed in previous 24 hours (measured in mg)

  7. Intravenous opioid consumption [ Time Frame: Days 1, 2, 7, 14 ]
    Recorded as the amount of intravenous morphine-equivalent analgesics consumed in previous 24 hours (measured in mg)

  8. Day of discharge [ Time Frame: through study completion, an average of 1 year ]
    The number of days following the study procedure of primary discharge from the hospital



Information from the National Library of Medicine

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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 a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint sustained within the previous 3 days (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
  • 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 the primary 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
  • flail chest
  • chest tube
  • fracture of the 1st rib on either side
  • any moderate or severe pain (NRS>3) unrelated to the rib fracture(s), as best determined by the patient and investigator

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): NCT04198662


Locations
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United States, California
University California San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University 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: NCT04198662    
Other Study ID Numbers: Rib Fracture & Spirometry/Cryo
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
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
Epinephrine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents