Rib FracturesEarly Phase 1NCT06299137
Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures
A Early Phase 1 study testing Serratus Anterior Plane Block and Ropivacaine injection in people with Rib Fractures and Pain Acute, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are: Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Pain Acute, Regional Anesthesia
- What is being tested?
- Serratus Anterior Plane Block and Ropivacaine injection
- Type of treatment
- Injection or infusion, 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
- 1 Jul 2024to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT
- pain score of 5/10.
- Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale
- perform an incentive spirometry and be able to cough on command
Who cannot join
- isolated rib fractures that do not include ribs T3-T9
- penetrating trauma, pregnancy
- requiring immediate surgical or procedural intervention
- known allergy to amide-type local anesthetics
- have a painful distracting injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures,
The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:
- Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
- Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.
Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.
- Conditions
- Rib Fractures, Pain Acute, Regional Anesthesia, Opioid Use
- Being tested
- Serratus Anterior Plane Block, Ropivacaine injection
- Keywords
- rib fractures, regional anesthesia, Opioid use, acute pain
- Medical subject headings
- Rib Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane BlockProcedure or surgery
Patients who undergo randomization to the intervention arm will undergo the Serratus Anterior Plane Block.
Ropivacaine injectionDrug
Also called Ropivacaine
For the Serratus Anterior Plane Block, Ropivacaine will be used as the anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care. No changes made or recommended to patients randomized to the control arm. |
| Intervention arm (Undergoes SAPB) | Experimental | Patients randomized to this arm will receive the Serratus Anterior Plane block. Receives: Procedure: Serratus Anterior Plane Block; Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIC Score
Determine if the SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. The PIC score is a scoring system that can be measured serially in patients with rib fractures to assess pulmonary function and to prognosticate clinical outcomes.
Measured: 5 hours
Secondary outcomes (1)
Total oral morphine equivalents over the first 24 hours
Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leland Perice, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299137
- Sponsor's protocol ID
- RE2022-0000000349
- Other IDs
- RE2022-0000000349
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this point as to where and how IPD will be shared for this pilot study.
Publications
Paul S, Bhoi SK, Sinha TP, Kumar G. Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. J Emerg Trauma Shock. 2020 Jul-Sep;13(3):208-212. doi: 10.4103/JETS.JETS_155_19. Epub 2020 Sep 18.
PubMed 33304071Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.
PubMed 35106815Lin J, Hoffman T, Badashova K, Motov S, Haines L. Serratus Anterior Plane Block in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 21;4(1):21-25. doi: 10.5811/cpcem.2019.11.44946. eCollection 2020 Feb.
PubMed 32064417Thiruvenkatarajan V, Cruz Eng H, Adhikary SD. An update on regional analgesia for rib fractures. Curr Opin Anaesthesiol. 2018 Oct;31(5):601-607. doi: 10.1097/ACO.0000000000000637.
PubMed 30020155Sarode AL, Ho VP, Pieracci FM, Moorman ML, Towe CW. The financial burden of rib fractures: National estimates 2007 to 2016. Injury. 2021 Aug;52(8):2180-2187. doi: 10.1016/j.injury.2021.05.027. Epub 2021 May 19.
PubMed 34059325Perice L, Azzo C, Cowan M, Kheirbek T, Driver L, Tokarz S, Gallegos H, Kharel R, Jarabana SG, Baird J, Pare JR. Serratus Anterior Plane Block for Acute Rib Fractures in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2026 May;33(5):e70338. doi: 10.1111/acem.70338.
PubMed 42159402
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures,
- ClinicalTrials.gov ID
- NCT06299137
- Acronym / sponsor ID
- RE2022-0000000349
- Conditions
- Rib Fractures, Pain Acute, Regional Anesthesia, Opioid Use
- Keywords
- rib fractures, regional anesthesia, Opioid use, acute pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Mar 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 clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:
- Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
- Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.
Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care. No changes made or recommended to patients randomized to the control arm. |
| Intervention arm (Undergoes SAPB) | Experimental | Procedure: Serratus Anterior Plane Block, Drug: Ropivacaine injectionPatients randomized to this arm will receive the Serratus Anterior Plane block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT
- pain score of 5/10.
- Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale
- perform an incentive spirometry and be able to cough on command
Key exclusion criteria (5 listed)
- isolated rib fractures that do not include ribs T3-T9
- penetrating trauma, pregnancy
- requiring immediate surgical or procedural intervention
- known allergy to amide-type local anesthetics
- have a painful distracting 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 |
|---|---|---|
| Serratus Anterior Plane BlockPatients who undergo randomization to the intervention arm will undergo the Serratus Anterior Plane Block. | Procedure or surgery | Intervention arm (Undergoes SAPB) |
| Ropivacaine injectionAlso: RopivacaineFor the Serratus Anterior Plane Block, Ropivacaine will be used as the anesthetic. | Drug | Intervention arm (Undergoes SAPB) |
Primary outcome
PIC Score
Time frame: 5 hours
Determine if the SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. The PIC score is a scoring system that can be measured serially in patients with rib fractures to assess pulmonary function and to prognosticate clinical outcomes.
1 secondary outcome
Total oral morphine equivalents over the first 24 hours
Time frame: 24 hours
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 18 Feb 2026.
- Background: PubMed 33304071Paul S, Bhoi SK, Sinha TP, Kumar G. Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. J Emerg Trauma Shock. 2020 Jul-Sep;13(3):208-212. doi: 10.4103/JETS.JETS_155_19. Epub 2020 Sep 18.
- Background: PubMed 35106815Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.
- Background: PubMed 32064417Lin J, Hoffman T, Badashova K, Motov S, Haines L. Serratus Anterior Plane Block in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 21;4(1):21-25. doi: 10.5811/cpcem.2019.11.44946. eCollection 2020 Feb.
- Background: PubMed 30020155Thiruvenkatarajan V, Cruz Eng H, Adhikary SD. An update on regional analgesia for rib fractures. Curr Opin Anaesthesiol. 2018 Oct;31(5):601-607. doi: 10.1097/ACO.0000000000000637.
- Background: PubMed 34059325Sarode AL, Ho VP, Pieracci FM, Moorman ML, Towe CW. The financial burden of rib fractures: National estimates 2007 to 2016. Injury. 2021 Aug;52(8):2180-2187. doi: 10.1016/j.injury.2021.05.027. Epub 2021 May 19.
- Derived from this study: PubMed 42159402Perice L, Azzo C, Cowan M, Kheirbek T, Driver L, Tokarz S, Gallegos H, Kharel R, Jarabana SG, Baird J, Pare JR. Serratus Anterior Plane Block for Acute Rib Fractures in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2026 May;33(5):e70338. doi: 10.1111/acem.70338.
- Individual participant dataSharing planned: Undecided. Undecided at this point as to where and how IPD will be shared for this pilot study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Serratus Anterior Plane Block and Ropivacaine injection in people with Rib Fractures and Pain Acute, run by Rhode Island Hospital 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 5 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 18 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?
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?
PIC Score (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299137, which also lists 6 linked publications.
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 18 Feb 2026.