Rib FracturesEarly Phase 1NCT04916691
Ultrasound-guided Erector Spinae Plane Blocks
A Early Phase 1 study testing EPSB for rib fractures and Ropivacaine in people with Rib Fractures, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rib Fractures
- What is being tested?
- EPSB for rib fractures and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 22 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years old or older.
- Patients with one or more acute traumatic rib fractures.
Who cannot join
- Inability to position appropriately.
- Unconscious or heavily sedated.
- Patients who are critically ill such that care should not be delayed for regional anesthesia.
- Patients under the age of 18 years old.
- Vulnerable populations including prison inmates and pregnant patients.
- Overlying skin infection, wound, or dressing/equipment (i.e., Chest tube).
- Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
- Known or documented allergy to ropivacaine or other amide local anesthetic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Erector Spinae Plane Block for Rib Fractures: A Pilot Study
The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).
- Conditions
- Rib Fractures
- Being tested
- EPSB for rib fractures, Ropivacaine
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPSB for rib fracturesProcedure or surgery
EPSB for rib fractures
RopivacaineDrug
Standard of care weight-based optimal Ropivacaine dosing for ESPB
| Study group | Role | What they receive |
|---|---|---|
| EPSB for rib fractures | Other | EPSB for rib fractures Receives: Procedure: EPSB for rib fractures; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Measuring the Number of successful ESPB procedures performed in the ED and ICU
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start15 May 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
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.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Stephens, Mayo Clinic
- Investigators
- Daniel Stephens, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916691
- Sponsor's protocol ID
- 19-007896
- Status last verified
- Jun 2023
- First submitted
- 20 May 2021
- Last updated
- 28 Jun 2023
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Rib Fractures: A Pilot Study
- ClinicalTrials.gov ID
- NCT04916691
- Acronym / sponsor ID
- 19-007896
- Conditions
- Rib Fractures
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 7 Jun 2021 (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 the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPSB for rib fractures | Other | Procedure: EPSB for rib fractures, Drug: RopivacaineEPSB for rib fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years old or older.
- Patients with one or more acute traumatic rib fractures.
Key exclusion criteria (8 listed)
- Inability to position appropriately.
- Unconscious or heavily sedated.
- Patients who are critically ill such that care should not be delayed for regional anesthesia.
- Patients under the age of 18 years old.
- Vulnerable populations including prison inmates and pregnant patients.
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 |
|---|---|---|
| EPSB for rib fracturesEPSB for rib fractures | Procedure or surgery | EPSB for rib fractures |
| RopivacaineStandard of care weight-based optimal Ropivacaine dosing for ESPB | Drug | EPSB for rib fractures |
Primary outcome
Procedural success rate
Time frame: 12 months
Measuring the Number of successful ESPB procedures performed in the ED and ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
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Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
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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
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RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
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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. This study is not recruiting at the moment.
Daniel Stephens, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EPSB for rib fractures and Ropivacaine in people with Rib Fractures, run by Mayo Clinic 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jun 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate (time frame: 12 months). 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 28 Jun 2023.