Rib Fracture Analgesia Using Cryoanalgesia

NCT04198662 | Completed Phase 4 Results FDA Device

• 1 other identifier: Rib Fracture & Spirometry/Cryo
• Study Type: interventional
• Target: 20
• 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 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)

Outcome Measures

Primary Outcomes (1)

• Maximum Inspired Volume

  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.

  Day 1 of study treatment

Secondary Outcomes (8)

• Maximum Inspired Volume

  Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2

• Spirometry Pain

  Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2

• Brief Pain Inventory (Pain Scale)

  Days 1, 2, and 7

• Brief Pain Inventory (Interference Scale)

  Day 14, and Months 1, 1.5, 2, 3, 6, and 12

• Sleep Disturbances Due to Pain

  Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12

Study Arms (2)

Cryoneurolysis and placebo intercostal nerve block

ACTIVE COMPARATOR

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); Drug: Placebo intercostal nerve block with normal saline

Sham cryoneurolysis and active intercostal nerve block

SHAM COMPARATOR

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; Device: Sham cryoneurolysis with a Painblocker

Interventions

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

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.

Cryoneurolysis and placebo intercostal nerve block

Intercostal nerve block ropivacaine with epinephrine DRUG

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

Sham cryoneurolysis and active intercostal nerve block

Sham cryoneurolysis with a Painblocker DEVICE

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.

Sham cryoneurolysis and active intercostal nerve block

Placebo intercostal nerve block with normal saline DRUG

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

Cryoneurolysis and placebo intercostal nerve block

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 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

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 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Interventions

Epinephrine; Saline Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

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

bilfeld@health.ucsd.edu

(858) 822-0776

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Multicenter, randomized, double-masked, sham-controlled, parallel design, clinical trial

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: April 3, 2020
• Primary Completion: August 28, 2023
• Study Completion: August 27, 2024
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)