Rib FracturesPhase 4NCT03619785
US-guided SAPB for Rib Fractures in the ED
A Phase 4 study testing Bupivacaine and Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen in people with Rib Fractures and Rib Fracture Multiple, run by Andrew A Herring at 1 site in United States.
Trial summary
The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Rib Fracture Multiple
- What is being tested?
- Bupivacaine and Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 31 Aug 2019
- Phase
- Phase 4
- 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
- Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
- Written informed consent must be obtained from each patient prior to entering the study.
- Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.
Who cannot join
- Patient refusal
- Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
- Patients deemed critically ill by provider
- Patients with decompensated psychiatric disorders
- Pregnant patients (positive urine or serum B-HCG)
- History of heart block or bradycardia
Show all 9Show fewer
- History of uncontrolled seizures
- Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
- Patients with bilateral rib fractures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Alameda Health System - Highland Hospital
Oakland, California, 94602
Jennifer Sun, jennsun@alamedahealthsystem.org
About this study
Official title: Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)
The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.
Read the detailed description
Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Being tested
- Bupivacaine, Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen
- Keywords
- Nerve Block, Serratus Anterior Plane Block, Ultrasound, Emergency Department
- Medical subject headings
- Rib Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.
Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofenDrug
Oral or IV pain medication as needed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (SAPB) | Experimental | Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain. Receives: Drug: Bupivacaine |
| Control | Active comparator | Patients randomized to the control arm receive usual pain control treatment in the emergency department. Receives: Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Change in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.
Measured: 60 minutes
Secondary outcomes (6)
Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups
Change in Numeric Pain Rating Scale score for resting chest pain and dynamic chest pain at 20, 40, and 60 minutes between block and control groups, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.
Measured: 20, 40, 60 minutes
Difference in total morphine equivalents
Difference in total parenteral morphine equivalents received during study period (0 minutes to 60 minutes) and at 4, 12, and 24 hours (unless discharged from the hospital prior to 24 hours) in the block and control groups.
Measured: 1, 4, 12, and 24 hours
Successful analgesia for block group
Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.
Measured: 20, 40, 60 minutes
Non-opioid medications given (yes/no)
NSAID, APAP, Gabapentin administered in block versus control groups.
Measured: 20, 40, 60 minutes
Adverse events
Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.
Measured: 60 minutes
Sensory testing
Sensory testing to cold stimulus (alcohol swab) in the block group along the lateral sternal, anterior axillary, and posterior axillary lines at the levels of T2-T10 using a 3-point scale: 0 (unchanged), 1 (reduced), or 2 (no sensation).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start6 Nov 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew A Herring
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew A Herring, Alameda Health System
- Investigators
- Andrew Herring, MD, Principal investigator, Alameda Health System - Highland HospitalJosh Luftig, PA, Principal investigator, Alameda Health System - Highland HospitalEben Clattenburg, MD, Principal investigator, Alameda Health System - Highland HospitalDaniel Mantuani, MD, MPH, Principal investigator, Alameda Health System - Highland HospitalArun Nagdev, MD, Principal investigator, Alameda Health System - Highland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619785
- Sponsor's protocol ID
- 17-10102B
- Status last verified
- Dec 2018
- First submitted
- 13 Jul 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT03619785
- Acronym / sponsor ID
- 17-10102B
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Keywords
- Nerve Block, Serratus Anterior Plane Block, Ultrasound, Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Andrew A HerringUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, University of California, Los Angeles
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 8 Aug 2018 (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 randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.
Detailed description
Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (SAPB) | Experimental | Drug: BupivacainePatients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain. |
| Control | Active comparator | Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofenPatients randomized to the control arm receive usual pain control treatment in the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
- Written informed consent must be obtained from each patient prior to entering the study.
- Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.
Key exclusion criteria (9 listed)
- Patient refusal
- Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
- Patients deemed critically ill by provider
- Patients with decompensated psychiatric disorders
- Pregnant patients (positive urine or serum B-HCG)
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 |
|---|---|---|
| BupivacainePatient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered. | Drug | Experimental (SAPB) |
| Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofenOral or IV pain medication as needed. | Drug | Control |
Primary outcome
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Time frame: 60 minutes
Change in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.
6 secondary outcomes
Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups
Time frame: 20, 40, 60 minutes
Difference in total morphine equivalents
Time frame: 1, 4, 12, and 24 hours
Successful analgesia for block group
Time frame: 20, 40, 60 minutes
Non-opioid medications given (yes/no)
Time frame: 20, 40, 60 minutes
Adverse events
Time frame: 60 minutes
Sensory testing
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- 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.
Andrew Herring, MD principal investigator
Alameda Health System - Highland Hospital
Josh Luftig, PA principal investigator
Alameda Health System - Highland Hospital
Eben Clattenburg, MD principal investigator
Alameda Health System - Highland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen in people with Rib Fractures and Rib Fracture Multiple, run by Andrew A Herring 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Dec 2018. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Herring (510-633-7498, aherring@alamedahealthsystem.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups (time frame: 60 minutes). 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 19 Dec 2018.