Phase 4 N=20 Randomized Triple-blind Treatment

Rib Fracture Analgesia Using Cryoanalgesia

Traumatic Rib Fracture(s)

Bottom Line

View on ClinicalTrials.gov: NCT04198662 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Maximum Inspired Volume — 2250; 1300 mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas) (Device); Intercostal nerve block ropivacaine with epinephrine (Drug); Sham cryoneurolysis with a Painblocker (Device); Placebo intercostal nerve block with normal saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Inspired Volume	1000; 1000; 2000; 1750; 2250; 1300	—
SECONDARY Maximum Inspired Volume	1000; 1000; 2000; 1750; 2250; 1300	—
SECONDARY Spirometry Pain	10; 10; 3; 5; 2; 8	—
SECONDARY Brief Pain Inventory (Pain Scale)	7; 28; 7; 21; 6; 26	—
SECONDARY Brief Pain Inventory (Interference Scale)	0; 30; 0; 24; 0; 1	—
SECONDARY Sleep Disturbances Due to Pain	0; 2; 0; 3; 0; 4	—
SECONDARY Oral Opioid Consumption	0; 35; 0; 18; 0; 15	—
SECONDARY Intravenous Opioid Consumption	0; 0; 0; 0; 0; 0	—
SECONDARY Day of Discharge	0.7; 1.4	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04198662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.