Rib Fracture MultipleNCT04311827
Serratus Anterior Plane Block for Improving Pain and Respiratory Function in Patients With Multiple Rib Fractures
An observational study of Rib Fracture Multiple, run by Stanford University at 1 site in United States.
Trial summary
This is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture Multiple
- What is being tested?
- Serratus Anterior Plane Block
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Participants will be patients who are 18 years and older (of all genders and ethnic backgrounds) presenting to the Stanford University Emergency Department with multiple, acute, unilateral, antero-lateral rib fractures who meet inclusion/exclusion criteria
Who may be able to join
- Age greater or equal to 18 years of age
- Presentation to Stanford University Hospital Emergency Department within 12 hours of a traumatic incident
- Three or more anterior and/or lateral unilateral rib fractures diagnosed by CT
- GCS 15, with the ability to discern and describe pain from rib fractures and give consent
- Presentation to the Emergency Department between 7am and 11pm (for identification by research assistants)
Who cannot join
- Posterior rib fractures
- Bilateral rib fractures
- Sternal fracture
- Known allergy to local anesthetics
- Pregnancy
- Significant coagulopathy
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital
Palo Alto, California, 94305
About this study
Official title: The Effect of the Serratus Anterior Plane Block in Improving Pain and Respiratory Function in Trauma Patients Presenting to the Emergency Department With Multiple Rib Fractures.
This is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. When resources are available for a SAPB to be performed, patients will receive this block in addition to traditional pain medications, while at other times, patients will receive traditional pain medications only.
Read the detailed description
Pain management by systemic analgesics and by nerve blocks are both standard of care and used in Emergency Department (ED) depending on the resources available. Not all ED physicians are trained or comfortable with the serratus anterior nerve block and thus it is not always available to patients and is provider dependent.
This is an observational study where patients with multiple rib fractures will receive either a serratus anterior plane block (SAPB) in addition to traditional forms of pain control when providers trained to perform the block are available, or will receive traditional forms pain control if trained personnel are not available. In addition to the serratus anterior plane block, standard forms of pain control in the Stanford Emergency Department include: oral or parenteral acetaminophen, oral or parenteral NSAIDs, oral or parenteral opiates, parenteral lidocaine, and parenteral ketamine.
Retrospective evaluation of the allocation of patients to either nerve block or no nerve block will be dictated by physician ability, time and resources to do the block. The efficacy of the block will be evaluated by serial measurements of pain score and respiratory capacity.
- Conditions
- Rib Fracture Multiple
- Being tested
- Serratus Anterior Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane BlockOther
Injection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block and traditional analgesia | Serratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed Receives: Other: Serratus Anterior Plane Block | |
| Traditional analgesia | Serratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
Patient reported pain score from 0-10 (0 - no pain, 10 = worst pain imaginable).
Measured: Before and 3 hours after analgesia administration
Change in incentive spirometry volume
Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
Measured: Before and 3 hours after analgesia administration
Secondary outcomes (1)
Analgesia administration
Dosage of analgesic medications administered for pain during ED visit and hospital stay
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rib Fracture MultipleStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Academic Emergency Medicine
- Responsible party
- Principal investigator, Youyou Duanmu, Stanford University
- Investigators
- Youyou Duanmu, MD, MPH, Principal investigator, STANFORD HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311827
- Sponsor's protocol ID
- 52801
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
PubMed 29301653Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.
PubMed 21256488Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
PubMed 27533913Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
PubMed 16269301Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f.
PubMed 21716105Thiruvenkatarajan 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 30020155Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.
PubMed 30740657Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.
PubMed 27595172Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.
PubMed 17161098Martin TJ, Eltorai AS, Dunn R, Varone A, Joyce MF, Kheirbek T, Adams C Jr, Daniels AH, Eltorai AEM. Clinical management of rib fractures and methods for prevention of pulmonary complications: A review. Injury. 2019 Jun;50(6):1159-1165. doi: 10.1016/j.injury.2019.04.020. Epub 2019 Apr 22.
PubMed 31047683
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Serratus Anterior Plane Block in Improving Pain and Respiratory Function in Trauma Patients Presenting to the Emergency Department With Multiple Rib Fractures.
- ClinicalTrials.gov ID
- NCT04311827
- Acronym / sponsor ID
- 52801
- Conditions
- Rib Fracture Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Society for Academic Emergency Medicine
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Mar 2020 (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.
This is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. When resources are available for a SAPB to be performed, patients will receive this block in addition to traditional pain medications, while at other times, patients will receive traditional pain medications only.
Detailed description
Pain management by systemic analgesics and by nerve blocks are both standard of care and used in Emergency Department (ED) depending on the resources available. Not all ED physicians are trained or comfortable with the serratus anterior nerve block and thus it is not always available to patients and is provider dependent.
This is an observational study where patients with multiple rib fractures will receive either a serratus anterior plane block (SAPB) in addition to traditional forms of pain control when providers trained to perform the block are available, or will receive traditional forms pain control if trained personnel are not available. In addition to the serratus anterior plane block, standard forms of pain control in the Stanford Emergency Department include: oral or parenteral acetaminophen, oral or parenteral NSAIDs, oral or parenteral opiates, parenteral lidocaine, and parenteral ketamine.
Retrospective evaluation of the allocation of patients to either nerve block or no nerve block will be dictated by physician ability, time and resources to do the block. The efficacy of the block will be evaluated by serial measurements of pain score and respiratory capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block and traditional analgesia | – | Other: Serratus Anterior Plane BlockSerratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed |
| Traditional analgesia | – | –Serratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients who are 18 years and older (of all genders and ethnic backgrounds) presenting to the Stanford University Emergency Department with multiple, acute, unilateral, antero-lateral rib fractures who meet inclusion/exclusion criteria
Key inclusion criteria (5 listed)
- Age greater or equal to 18 years of age
- Presentation to Stanford University Hospital Emergency Department within 12 hours of a traumatic incident
- Three or more anterior and/or lateral unilateral rib fractures diagnosed by CT
- GCS 15, with the ability to discern and describe pain from rib fractures and give consent
- Presentation to the Emergency Department between 7am and 11pm (for identification by research assistants)
Key exclusion criteria (7 listed)
- Posterior rib fractures
- Bilateral rib fractures
- Sternal fracture
- Known allergy to local anesthetics
- Pregnancy
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 BlockInjection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line | Other | Serratus anterior plane block and traditional analgesia |
Primary outcome
Change in pain score
Time frame: Before and 3 hours after analgesia administration
Patient reported pain score from 0-10 (0 - no pain, 10 = worst pain imaginable).
Change in incentive spirometry volume
Time frame: Before and 3 hours after analgesia administration
Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
1 secondary outcome
Analgesia administration
Time frame: Up to 3 days
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 25 Aug 2022.
- Background: PubMed 29301653Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
- Background: PubMed 21256488Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.
- Background: PubMed 27533913Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
- Background: PubMed 16269301Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
- Background: PubMed 21716105Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f.
- 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 30740657Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.
- Background: PubMed 27595172Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.
- Background: PubMed 17161098Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.
- Background: PubMed 31047683Martin TJ, Eltorai AS, Dunn R, Varone A, Joyce MF, Kheirbek T, Adams C Jr, Daniels AH, Eltorai AEM. Clinical management of rib fractures and methods for prevention of pulmonary complications: A review. Injury. 2019 Jun;50(6):1159-1165. doi: 10.1016/j.injury.2019.04.020. Epub 2019 Apr 22.
- Individual participant dataSharing planned: No
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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.
Youyou Duanmu, MD, MPH principal investigator
STANFORD HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fracture Multiple, run by Stanford 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 5 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: finished, as of the sponsor's last update on 25 Aug 2022. 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.
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?
Change in pain score (time frame: Before and 3 hours after analgesia administration). The study lists 2 primary outcomes in all. 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 NCT04311827, which also lists 10 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 25 Aug 2022.