An observational study in Rib Fracture Multiple, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Stanford University · Observational
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.
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.
14 studies on the registry are indexed under Fractures, Multiple; 4 are open to participants now.
Browse Fractures, Multiple studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: Serratus Anterior Plane Block
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
Injection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line
Change in pain score
Patient reported pain score from 0-10 (0 - no pain, 10 = worst pain imaginable).
Time frame: 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
Time frame: Before and 3 hours after analgesia administration
Analgesia administration
Dosage of analgesic medications administered for pain during ED visit and hospital stay
Time frame: Up to 3 days
Plan to share: No
Ran from Mar 2020 to primary completion in Dec 2021, 21 months.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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