US-guided SAPB for Rib Fractures in the ED
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|ClinicalTrials.gov Identifier: NCT03619785|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : December 19, 2018
|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).
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|