Rib FracturesPhase 4NCT06347874
Cryo Rib Fracture Study
A Phase 4 study testing Cryoablation and ESP Catheter in people with Rib Fractures, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Cryoablation and ESP Catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 13 Mar 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are over 18 who have more than one ribs fractured.
Who cannot join
- Patients who have an exclusion to regional anesthesia.
- Patients who are pregnant via self-report or pregnancy test if they take one.
- Non-English speakers
- Patients who have cold urticaria
- Patients with bilateral fractures
- Patients currently intubated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Candace Nelson contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Allicia Bulleri
About this study
Official title: Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures
The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.
- Conditions
- Rib Fractures
- Being tested
- Cryoablation, ESP Catheter
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDrug
an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves
ESP CatheterDrug
an ultrasound guided erector spinae plane catheter with initial bolus of 30 mL of 0.25% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour via programmed intermittent bolus.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Participants with rib fracture randomized to Cryoablation. Receives: Drug: Cryoablation |
| ESP catheter | Active comparator | Participants with rib fracture randomized to ESP Catheter. Receives: Drug: ESP Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score on POD (Post Operative Day) 7
Maximum pain score on POD (Post Operative Day) 7
Measured: 7 days post procedure
Opioid Use
Opioid Use measured in MMEs
Measured: 30 days post procedure
Functional Pain Scores
Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30
Measured: 30 days post procedure
Number of Patients using opioids at POD 30
, Number of Patients using opioids at POD 30
Measured: 30 days post procedure
Length of hospital stay
Length of hospital stay measured in days:hours:minutes
Measured: 30 days post procedure
Number of patients returned home by POD 30
Number of patients returned home by POD 30
Measured: 30 days post procedure
time to first ambulation
time to first ambulation measured in days:hours:minutes
Measured: 30 days post procedure
number of patients admitted to ICU
number of patients admitted to ICU
Measured: 30 days post procedure
number of patients that required mechanical ventilation
number of patients that required mechanical ventilation
Measured: 30 days post procedure
Pulmonary Function Testing.
Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start10 Jan 2025
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Hanson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347874
- Sponsor's protocol ID
- ANES-2024-32820
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures
- ClinicalTrials.gov ID
- NCT06347874
- Acronym / sponsor ID
- ANES-2024-32820
- Conditions
- Rib Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 4 Apr 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 purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Drug: CryoablationParticipants with rib fracture randomized to Cryoablation. |
| ESP catheter | Active comparator | Drug: ESP CatheterParticipants with rib fracture randomized to ESP Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are over 18 who have more than one ribs fractured.
Key exclusion criteria (6 listed)
- Patients who have an exclusion to regional anesthesia.
- Patients who are pregnant via self-report or pregnancy test if they take one.
- Non-English speakers
- Patients who have cold urticaria
- Patients with bilateral fractures
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 |
|---|---|---|
| Cryoablationan injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves | Drug | Cryoablation |
| ESP Catheteran ultrasound guided erector spinae plane catheter with initial bolus of 30 mL of 0.25% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour via programmed intermittent bolus. | Drug | ESP catheter |
Primary outcome
Maximum pain score on POD (Post Operative Day) 7
Time frame: 7 days post procedure
Maximum pain score on POD (Post Operative Day) 7
Opioid Use
Time frame: 30 days post procedure
Opioid Use measured in MMEs
Functional Pain Scores
Time frame: 30 days post procedure
Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30
Number of Patients using opioids at POD 30
Time frame: 30 days post procedure
, Number of Patients using opioids at POD 30
Length of hospital stay
Time frame: 30 days post procedure
Length of hospital stay measured in days:hours:minutes
Number of patients returned home by POD 30
Time frame: 30 days post procedure
Number of patients returned home by POD 30
time to first ambulation
Time frame: 30 days post procedure
time to first ambulation measured in days:hours:minutes
number of patients admitted to ICU
Time frame: 30 days post procedure
number of patients admitted to ICU
number of patients that required mechanical ventilation
Time frame: 30 days post procedure
number of patients that required mechanical ventilation
Pulmonary Function Testing.
Time frame: 30 days post procedure
Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups.
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 17 Feb 2026.
Related trials for Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
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.
Candace Nelson contact
Neil Hanson principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryoablation and ESP Catheter in people with Rib Fractures, run by University of Minnesota 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Candace Nelson (nelso377@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum pain score on POD (Post Operative Day) 7 (time frame: 7 days post procedure). The study lists 10 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 17 Feb 2026.