TraumaNCT06533904
Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
A study testing Percutaneous Cryoablation of Intercostal Nerves and Multi-modal pain regimen in people with Trauma and Rib Fractures, run by Loma Linda University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Rib Fractures, Chest Wall Disorder
- What is being tested?
- Percutaneous Cryoablation of Intercostal Nerves and Multi-modal pain regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- > 2 rib fractures
- Verbal Pain score > 5
- Incentive Spirometry < 60% of predicted
Who cannot join
- 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
- Open Abdominothoracic Surgery
- Unstable Spine
Show all 19Show fewer
- Extensive Subcutaneous Emphysema
- BMI > 35
- Plan for Rib Plating
- Chronic Opioid Use
- Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy
- Coagulopathy, Shock at time of ablation
- Inability to participate in activities of daily living prior to injury
- Home O2 use prior to trauma
- Inhalation Injury
- Rib Fractures due to cardiopulmonary resuscitation
- Life Expectancy < 6 months
- > 48 hours from injury
- Pregnant, Incarcerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
Martin G Rosenthal, MD, 909-558-4286, mrosenthal@llu.edu
Matthew E Reeves, MD, 909-558-4289, mareeves@llu.edu
About this study
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?
Read more
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.
- Conditions
- Trauma, Rib Fractures, Chest Wall Disorder, Respiratory Insufficiency, Pain, Chest, Rib Trauma
- Being tested
- Percutaneous Cryoablation of Intercostal Nerves, Multi-modal pain regimen
- Keywords
- Trauma, Respiratory Failure, Respiratory Distress, Respiratory Insufficiency, Rib Fractures, Chest Wall Trauma, Percutaneous Cryoablation, Multimodal Pain Therapy, Multimodal Pain Regimen
- Medical subject headings
- Wounds and Injuries, Rib Fractures, Respiratory Insufficiency, Chest Pain, Respiratory Distress Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Cryoablation of Intercostal NervesProcedure or surgery
Percutaneous Cryoablation of Intercostal Nerves
Multi-modal pain regimenOther
Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)
| Study group | Role | What they receive |
|---|---|---|
| Standard multi-modal pain regimen alone | Placebo comparator | Not described Receives: Other: Multi-modal pain regimen |
| Standard multi-modal pain regimen with percutaneous cryoablation | Experimental | Not described Receives: Procedure: Percutaneous Cryoablation of Intercostal Nerves; Other: Multi-modal pain regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year
Rate of abnormal respiratory mechanics: Incentive Spirometry
Measured: Through study completion, up to 1 year
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)
Measured: Through study completion, up to 1 year
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
Measured: Through study completion, up to 1 year
Quality of Life on Survey
Long Term Quality of Life
Measured: Through study completion, up to 1 year
Secondary outcomes (9)
Rate of Pneumonia
Measured: Through study completion, up to 1 year
Rate of need for Intubation/Mechanical Ventilation
Measured: Through study completion, up to 1 year
Rate of need for tracheostomy
Measured: Through study completion, up to 1 year
Number of Ventilatory Days
Measured: Through study completion, up to 1 year
ICU Length of Stay
Measured: Through study completion, up to 1 year
Hospital Length of Stay
Measured: Through study completion, up to 1 year
Acute Respiratory Distress Syndrome
Measured: Through study completion, up to 1 year
Rate of Mortality
Measured: Through study completion, up to 1 year
Rate of Pleural Space Complications
Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533904
- Sponsor's protocol ID
- 5240003
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
- ClinicalTrials.gov ID
- NCT06533904
- Acronym / sponsor ID
- 5240003
- Conditions
- Trauma, Rib Fractures, Chest Wall Disorder, Respiratory Insufficiency, Pain, Chest, Rib Trauma
- Keywords
- Trauma, Respiratory Failure, Respiratory Distress, Respiratory Insufficiency, Rib Fractures, Chest Wall Trauma, Percutaneous Cryoablation, Multimodal Pain Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.
| Arm | Type | Receives |
|---|---|---|
| Standard multi-modal pain regimen alone | Placebo comparator | Other: Multi-modal pain regimen |
| Standard multi-modal pain regimen with percutaneous cryoablation | Experimental | Procedure: Percutaneous Cryoablation of Intercostal Nerves, Other: Multi-modal pain regimen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old
- > 2 rib fractures
- Verbal Pain score > 5
- Incentive Spirometry < 60% of predicted
Key exclusion criteria (19 listed)
- 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
- Open Abdominothoracic Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Cryoablation of Intercostal NervesPercutaneous Cryoablation of Intercostal Nerves | Procedure or surgery | Standard multi-modal pain regimen with percutaneous cryoablation |
| Multi-modal pain regimenStandard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural) | Other | Standard multi-modal pain regimen alone, Standard multi-modal pain regimen with percutaneous cryoablation |
Primary outcome
Pain Score: Numeric Pain Scale
Time frame: Through study completion, up to 1 year
Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome.
Rate of abnormal respiratory mechanics: Incentive Spirometry
Time frame: Through study completion, up to 1 year
Rate of abnormal respiratory mechanics: Pulmonary Function Tests
Time frame: Through study completion, up to 1 year
Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
Rate of delirium: Confusion Assessment Method (CAM) Score
Time frame: Through study completion, up to 1 year
The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium
Quality of Life on Survey
Time frame: Through study completion, up to 1 year
Long Term Quality of Life
9 secondary outcomes
Rate of Pneumonia
Time frame: Through study completion, up to 1 year
Rate of need for Intubation/Mechanical Ventilation
Time frame: Through study completion, up to 1 year
Rate of need for tracheostomy
Time frame: Through study completion, up to 1 year
Number of Ventilatory Days
Time frame: Through study completion, up to 1 year
ICU Length of Stay
Time frame: Through study completion, up to 1 year
Hospital Length of Stay
Time frame: Through study completion, up to 1 year
Acute Respiratory Distress Syndrome
Time frame: Through study completion, up to 1 year
Rate of Mortality
Time frame: Through study completion, up to 1 year
Rate of Pleural Space Complications
Time frame: Through study completion, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Cryoablation of Intercostal Nerves and Multi-modal pain regimen in people with Trauma and Rib Fractures, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score: Numeric Pain Scale (time frame: Through study completion, up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.