Exparel for Pain Control During Care of Rib Fractures



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:April 2015
End Date:April 2016
Contact:Annemarie Dalton
Email:adalton3@kumc.edu
Phone:913-588-0068

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Liposomal Bupivicaine (Exparel) for Pain Control During Care of Rib Fractures

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).

Inclusion Criteria:

- patients 18 years of age or older

- patients with three or more rib fractures occurring either unilaterally or
bilaterally

- patients who are awake enough to assess pain severity

Exclusion Criteria:

- patients whose pain in other anatomical areas limit rib fracture pain assessment

- patients with a history of hypersensitivity or idiosyncratic reactions or intolerance
to any local anesthetic, opioids, or ketorolac

- patients who abuse alcohol or other drug substances

- patients on chronic opioid therapy (taken an opioid 5 of the last 7 days)

- pregnant patients

- severe hepatic impairment

- persistent pain patients requiring 20mg oral morphine equivalent or greater in the 24
hour period prior to sustaining multiple rib fractures

- allergies to common agents used in Exparel (bupivacaine, liposome)

- inability to provide informed consent
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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