Rib FracturesPhase 1/2NCT04168710
Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
A Phase 1/2 study testing ESP block with bupivacaine in people with Rib Fractures, run by Yale University.
Trial summary
The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome. 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?
- ESP block with bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to May 2027
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiographic evidence of unilateral rib fracture(s).
- able to consent and actively participate in the study.
- moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.
Who cannot join
- known allergy or hypersensitivity to local anesthetics or morphine.
- infection at site of ESP block placement.
- depth over 5 cm from skin to transverse process visualized with ultrasound.
- additional injuries that preclude positioning for ESP block placement.
- severe traumatic brain or spinal cord injury.
- severe altered mental status, such that pain could not be assessed.
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- extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
- adjunctive epidural catheter pain control.
- other regional anesthetic blocks.
- pregnancy or prisoner status.
- unstable vital signs.
About this study
The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
Read the detailed description
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.
Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.
Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
- Conditions
- Rib Fractures
- Being tested
- ESP block with bupivacaine, Saline control/sham injection
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block with bupivacaineDrug
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
Saline control/sham injectionOther
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block (ESP block) with bupivacaine | Experimental | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle. Receives: Drug: ESP block with bupivacaine |
| ESP block with saline/sham injection | Placebo comparator | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle. Receives: Other: Saline control/sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous (IV) and oral narcotic analgesic use
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
Measured: From enrollment/baseline in the study through the study period, up to 24 hours.
Secondary outcomes (10)
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: Baseline (immediately following recruitment).
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: 30 minutes post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: 1 hour post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: 4 hours post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: 12 hours post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Measured: 24 hours post-baseline
Hospital length of stay (LOS)
LOS will be identified through the electronic medical record.
Measured: From hospital admission to hospital discharge, up to 30 days.
Number of Patients Who Develop Pneumonia
Identified through review of the electronic medical record for a discharge diagnosis of pneumonia, or readmission diagnosis of pneumonia within 1 month from presentation.
Measured: From admission to 30 days from admission.
Adverse events associated with the nerve block itself.
Adverse events will include: hypotension, respiratory depression, and nausea or vomiting. Hypotension will be defined as a systolic blood pressure < 90 mmHg and respiratory depression as respiratory rate < 10 breaths per minute. Nausea or vomiting will be defined as patient-reported sensation of nausea or actual emesis, documented emesis in the medical record, or administration of an antiemetic during the study period.
Measured: Within two hours of administration of the nerve block.
Total non-narcotic analgesic use.
Non-narcotic analgesic use will be measured by medical record review of all non-narcotic medications. Groups will be compared with respect to each category: non-steroidal anti-inflammatory use, acetaminophen use, local anesthetic patch use.
Measured: From enrollment/baseline in the study through the study period, up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 May 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: lack of enrollment
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 Yale 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiana Baloescu, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168710
- Sponsor's protocol ID
- 2000025328
- Other IDs
- No NIH funding
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2019
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
- ClinicalTrials.gov ID
- NCT04168710
- Acronym / sponsor ID
- 2000025328
- Conditions
- Rib Fractures
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Nov 2019 (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 study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
Detailed description
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.
Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.
Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block (ESP block) with bupivacaine | Experimental | Drug: ESP block with bupivacaineEach participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle. |
| ESP block with saline/sham injection | Placebo comparator | Other: Saline control/sham injectionEach participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- radiographic evidence of unilateral rib fracture(s).
- able to consent and actively participate in the study.
- moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.
Key exclusion criteria (11 listed)
- known allergy or hypersensitivity to local anesthetics or morphine.
- infection at site of ESP block placement.
- depth over 5 cm from skin to transverse process visualized with ultrasound.
- additional injuries that preclude positioning for ESP block placement.
- severe traumatic brain or spinal cord injury.
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 |
|---|---|---|
| ESP block with bupivacaineEach participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle. | Drug | erector spinae plane block (ESP block) with bupivacaine |
| Saline control/sham injectionEach participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle. | Other | ESP block with saline/sham injection |
Primary outcome
Total intravenous (IV) and oral narcotic analgesic use
Time frame: From enrollment/baseline in the study through the study period, up to 24 hours.
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
10 secondary outcomes
Pain score
Time frame: Baseline (immediately following recruitment).
Pain score
Time frame: 30 minutes post-baseline
Pain score
Time frame: 1 hour post-baseline
Pain score
Time frame: 4 hours post-baseline
Pain score
Time frame: 12 hours post-baseline
Pain score
Time frame: 24 hours post-baseline
Hospital length of stay (LOS)
Time frame: From hospital admission to hospital discharge, up to 30 days.
Number of Patients Who Develop Pneumonia
Time frame: From admission to 30 days from admission.
Adverse events associated with the nerve block itself.
Time frame: Within two hours of administration of the nerve block.
Total non-narcotic analgesic use.
Time frame: From enrollment/baseline in the study through the study period, up to 24 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Rib Fractures
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INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
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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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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
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.
Cristiana Baloescu, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ESP block with bupivacaine in people with Rib Fractures, run by Yale University.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Total intravenous (IV) and oral narcotic analgesic use (time frame: From enrollment/baseline in the study through the study period, up to 24 hours.). 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 1 Jul 2025.