US-guided SAPB for Rib Fractures in the ED
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|ClinicalTrials.gov Identifier: NCT03619785|
Recruitment Status : Unknown
Verified December 2018 by Andrew A Herring, Alameda Health System.
Recruitment status was: Recruiting
First Posted : August 8, 2018
Last Update Posted : December 19, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Rib Fractures Rib Fracture Multiple||Drug: Bupivacaine Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: Experimental (SAPB)
Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.
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.
Active Comparator: Control
Patients randomized to the control arm receive usual pain control treatment in the emergency department.
Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen
Oral or IV pain medication as needed.
- 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.
- 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 ]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.
- Difference in total morphine equivalents [ Time Frame: 1, 4, 12, and 24 hours ]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.
- Successful analgesia for block group [ Time Frame: 20, 40, 60 minutes ]Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.
- Non-opioid medications given (yes/no) [ Time Frame: 20, 40, 60 minutes ]NSAID, APAP, Gabapentin administered in block versus control groups.
- Adverse events [ Time Frame: 60 minutes ]Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.
- Sensory testing [ Time Frame: 60 minutes ]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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- History of uncontrolled seizures
- Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
- Patients with bilateral rib fractures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619785
|Contact: Andrew Herringfirstname.lastname@example.org|
|Contact: Jennifer Sunemail@example.com|
|United States, California|
|Alameda Health System - Highland Hospital||Recruiting|
|Oakland, California, United States, 94602|
|Contact: Jennifer Sun firstname.lastname@example.org|
|Principal Investigator:||Andrew Herring, MD||Alameda Health System - Highland Hospital|
|Principal Investigator:||Josh Luftig, PA||Alameda Health System - Highland Hospital|
|Principal Investigator:||Eben Clattenburg, MD||Alameda Health System - Highland Hospital|
|Principal Investigator:||Daniel Mantuani, MD, MPH||Alameda Health System - Highland Hospital|
|Principal Investigator:||Arun Nagdev, MD||Alameda Health System - Highland Hospital|
|Responsible Party:||Andrew A Herring, Associate Research Director, Department of Emergency Medicine, Highland Hospital, Alameda Health System|
|Other Study ID Numbers:||
|First Posted:||August 8, 2018 Key Record Dates|
|Last Update Posted:||December 19, 2018|
|Last Verified:||December 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Serratus Anterior Plane Block
Wounds and Injuries
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action