Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLoma Linda University

About this trial

The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are:

Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium?

Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery.

Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

> 18 years old

> 2 rib fractures

Verbal Pain score > 5

Incentive Spirometry < 60% of predicted

Disqualifiers

Isolated Fractures of Ribs 1-3 and/or 10-12

Posterior Rib Fracture < 4 cm from costovertebral joint

Sternal, Clavicle, Scapula Fracture

Thoracic Spinal Fracture of any type

Trial design

Design model

Single group

Treatments tested in this trial

  • Percutaneous Cryoablation of Intercostal Nerves

    Procedure/Surgery

    Percutaneous Cryoablation of Intercostal Nerves

  • Multi-modal pain regimen

    Other intervention

    Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard multi-modal pain regimen alonePlacebo comparator 1 intervention
Group B: Standard multi-modal pain regimen with percutaneous cryoablationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain Score: Numeric Pain Scale

Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome.

Time frame
Through study completion, up to 1 year
2

Rate of abnormal respiratory mechanics: Incentive Spirometry

Time frame
Through study completion, up to 1 year
3

Rate of abnormal respiratory mechanics: Pulmonary Function Tests

Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)

Time frame
Through study completion, up to 1 year
4

Rate of delirium: Confusion Assessment Method (CAM) Score

The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium

Time frame
Through study completion, up to 1 year

Secondary outcomes

1

Rate of Pneumonia

Time frame
Through study completion, up to 1 year
2

Rate of need for Intubation/Mechanical Ventilation

Time frame
Through study completion, up to 1 year
3

Rate of need for tracheostomy

Time frame
Through study completion, up to 1 year
4

Number of Ventilatory Days

Time frame
Through study completion, up to 1 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: