A Phase 4 interventional study of Bupivacaine and Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen in Rib Fractures and Rib Fracture Multiple, sponsored by Andrew A Herring. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Andrew A Herring · Phase 4, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →This is the only study on the registry with Andrew A Herring as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.
Drug: Bupivacaine
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
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.
Drug pages: 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
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.
Time frame: 60 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 20, 40, 60 minutes
Non-opioid medications given (yes/no)
NSAID, APAP, Gabapentin administered in block versus control groups.
Time frame: 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.
Time frame: 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).
Time frame: 60 minutes
Plan to share: No
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Studies of the drug tested here: Bupivacaine