Rib FracturesPhase 1NCT03805360
The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
A Phase 1 study testing Ropivacaine and Normal Saline Flush, 0.9% Injectable Solution in people with Rib Fractures, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care. 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?
- Ropivacaine and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 10 Jan 2020
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blunt chest trauma
- Sustaining at least 3 unliateral rib fractures
- Resultant vital capacity less than 30% predicted
- Pain score reaches threshold despite using the current institutional standard of care for pain control
Who cannot join
- Patients whose weight less than 60kg.
- Patients with bilateral rib fractures.
- Patients that are intubated and mechanically ventilated.
- Pregnant Individuals.
- Any individual with a documented allergy to ropivacaine.
- Patients with limited English proficiency (LEP)
- Patients whose body habitus prevents the practitioner's ability to adequately perform the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.
Read the detailed description
Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry significant risk in terms of patient morbidity and mortality. Pulmonary complications resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission, and prolonged hospital stay. Many institutions have tried to develop protocols to risk stratify and appropriately treat these patients, with the goal of predicting those with higher likelihood of pulmonary complications in order to minimize additional morbidity. Studies have demonstrated critical spirometry values which correlate to worse patient outcomes; specifically, vital capacity less than 50% predicted, or less than 2L. Subsequently, there have been numerous attempts to identify the best treatment interventions for these high risk patients. In addition to multi-modal pain management, the most commonly used procedures include thoracic epidurals, continuous or single shot paravertebral blocks, and intercostal blocks. However, all of the above interventions carry significant risk, and the frequent use lovenox thromboprophylaxis drastically limit their use. Recently, a novel peripheral nerve block technique has been developed, an erector spinae plane block (ESP), which may provide similar or greater efficacy to the above, with significantly less risk to the patient.
- Conditions
- Rib Fractures
- Being tested
- Ropivacaine, Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Local anesthetic
Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.
Normal Saline Flush, 0.9% Injectable SolutionDrug
Also called 0.9% Sodium Chloride
Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.
| Study group | Role | What they receive |
|---|---|---|
| ESP block with normal saline | Sham comparator | An erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane. Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
| ESP block with local anesthetic | Experimental | An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numeric pain score rating at rest (before incentive spirometry exercise)
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
Measured: Baseline and at 45 minutes after ESP block
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
Measured: Baseline and at 45 minutes after ESP block
Change in incentive spirometry values
Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.
Measured: Baseline and at 45 minutes after ESP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start24 May 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Why it stopped: Insufficient 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryant Tran, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805360
- Sponsor's protocol ID
- HM20014264
- Status last verified
- Aug 2020
- First submitted
- 10 Jan 2019
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
- ClinicalTrials.gov ID
- NCT03805360
- Acronym / sponsor ID
- HM20014264
- Conditions
- Rib Fractures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 15 Jan 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 purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.
Detailed description
Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry significant risk in terms of patient morbidity and mortality. Pulmonary complications resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission, and prolonged hospital stay. Many institutions have tried to develop protocols to risk stratify and appropriately treat these patients, with the goal of predicting those with higher likelihood of pulmonary complications in order to minimize additional morbidity. Studies have demonstrated critical spirometry values which correlate to worse patient outcomes; specifically, vital capacity less than 50% predicted, or less than 2L. Subsequently, there have been numerous attempts to identify the best treatment interventions for these high risk patients. In addition to multi-modal pain management, the most commonly used procedures include thoracic epidurals, continuous or single shot paravertebral blocks, and intercostal blocks. However, all of the above interventions carry significant risk, and the frequent use lovenox thromboprophylaxis drastically limit their use. Recently, a novel peripheral nerve block technique has been developed, an erector spinae plane block (ESP), which may provide similar or greater efficacy to the above, with significantly less risk to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.
| Arm | Type | Receives |
|---|---|---|
| ESP block with normal saline | Sham comparator | Drug: Normal Saline Flush, 0.9% Injectable SolutionAn erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane. |
| ESP block with local anesthetic | Experimental | Drug: RopivacaineAn erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Blunt chest trauma
- Sustaining at least 3 unliateral rib fractures
- Resultant vital capacity less than 30% predicted
- Pain score reaches threshold despite using the current institutional standard of care for pain control
Key exclusion criteria (7 listed)
- Patients whose weight less than 60kg.
- Patients with bilateral rib fractures.
- Patients that are intubated and mechanically ventilated.
- Pregnant Individuals.
- Any individual with a documented allergy to ropivacaine.
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 |
|---|---|---|
| RopivacaineAlso: Local anestheticRopivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane. | Drug | ESP block with local anesthetic |
| Normal Saline Flush, 0.9% Injectable SolutionAlso: 0.9% Sodium ChlorideNormal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane. | Drug | ESP block with normal saline |
Primary outcome
Change in numeric pain score rating at rest (before incentive spirometry exercise)
Time frame: Baseline and at 45 minutes after ESP block
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Time frame: Baseline and at 45 minutes after ESP block
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
Change in incentive spirometry values
Time frame: Baseline and at 45 minutes after ESP block
Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
Related trials for Rib Fractures
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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.
Bryant Tran, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ropivacaine and Normal Saline Flush, 0.9% Injectable Solution in people with Rib Fractures, run by Virginia Commonwealth 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 7 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: stopped early, as of the sponsor's last update on 7 Aug 2020. 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.
What does this 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.
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 stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
Change in numeric pain score rating at rest (before incentive spirometry exercise) (time frame: Baseline and at 45 minutes after ESP block). The study lists 3 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 7 Aug 2020.