A Phase 4 interventional study of EXPAREL in Pain, sponsored by Michael Moncure, MD. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by Michael Moncure, MD · Phase 4, Interventional, and Treatment
This study is looking at a novel therapy of numbing medication injected directly around the fracture site. The purpose of this study is to determine if the study medication, EXPAREL®, is a viable alternative to current therapies for rib fractures.
Rib fractures are common in patients who have suffered a traumatic injury, occurring in about 10% of general injury cases and in about 30% of cases where the injury is directly to the chest. Usually caused by injury to the chest wall, rib fractures most often occur where the ribs bend and are most fragile. These kinds of injuries are commonly caused by motor vehicle collisions, falls, assault, industrial accidents, gunshots, or repetitive causes such as severe coughing or use-injury in athletes. With any of these types of injury, the first concern of the physician is to repair any immediate damage to the chest wall (such as penetrating wounds, air or blood in the chest cavity that compresses the lung(s), or fixing the broken ribs in place). Once these injuries are repaired and stabilized, the patient's care consists of controlling their pain and helping them recover normal breathing ability.
In patients who are not admitted to the hospital for care, usually with only 1 or 2 ribs broken, care is often pain control using over the counter medicines like Tylenol or Ibuprofen (called NSAIDS) or prescription medicines like hydrocodone (Vicodin®). The main concern during follow-up of these patients is full recovery of pain-free breathing ability. In patients who are admitted to the hospital for treatment, pneumonia is the most common complication associated with multiple broken ribs. Pneumonia occurs in anywhere from 15% to 30% of these patients. For long-acting pain control to help them breathe more easily, studies have shown that epidural analgesia (pain relieving drugs delivered through a thin tube called a catheter into the fluid surrounding the spinal cord) is preferable over opioids, whether given in pill form or through an IV. Additional studies have shown better results with epidural pain control compared to opioid or NSAID use. However, with all of these methods come risks and side effects.
Using oral NSAIDs can result in stomach irritation, kidney injury, or can interfere with the body's ability to form blood clots. Acetaminophen (Tylenol) has been shown to be toxic to the liver at higher doses. Opioid use can lower a person's breathing ability even while it reduces their pain, which is not wanted in patients already at higher risk for pneumonia. Epidural placement is a complex procedure, risks infection at the site of catheter insertion, can cause itching, and risks injury to both the spinal cord and the membrane surrounding it (the dura).
131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.
Browse Rib Fractures studies →This is the only study on the registry with Michael Moncure, MD as lead sponsor.
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Exclusion Criteria:
single dose, 266mg (20mL) of EXPAREL injected to slowly infiltrate the soft tissue around the site of fracture
Drug: EXPAREL
Also known as: Liposomal Bupivicaine
Pain relief (visual analog scale)
pain relief as measured by visual analog scale and patient satisfaction survey, before and after drug administration
Time frame: Change from Treatment to Hour 72
Length of hospital stay post treatment
count of days participant in hospital post treatment
Time frame: Up to 10 days, average length of stay expected to be 3 days
opioid use
Time frame: Change from Treatment to Hour 72
change in lung function as evidenced by use of incentive spirometry
Changes will be measured by using incentive spirometry. The incentive spirometry device includes an indicator which measures sustained inhalation vacuum. Change between performance will be measured at treatment to hour 72.
Time frame: Change from Treatment to Hour 72
This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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