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Exparel for Pain Control During Care of Rib Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390440
Recruitment Status : Withdrawn (Did not obtain an IND.)
First Posted : March 17, 2015
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Moncure, MD, University of Kansas Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: EXPAREL Phase 4

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liposomal Bupivicaine (Exparel) for Pain Control During Care of Rib Fractures
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EXPAREL
single dose, 266mg (20mL) of EXPAREL injected to slowly infiltrate the soft tissue around the site of fracture
Drug: EXPAREL
Other Name: Liposomal Bupivicaine




Primary Outcome Measures :
  1. Pain relief (visual analog scale) [ Time Frame: Change from Treatment to Hour 72 ]
    pain relief as measured by visual analog scale and patient satisfaction survey, before and after drug administration


Secondary Outcome Measures :
  1. Length of hospital stay post treatment [ Time Frame: Up to 10 days, average length of stay expected to be 3 days ]
    count of days participant in hospital post treatment

  2. opioid use [ Time Frame: Change from Treatment to Hour 72 ]
  3. change in lung function as evidenced by use of incentive spirometry [ Time Frame: Change from Treatment to Hour 72 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02390440


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Michael Moncure, MD
Investigators
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Principal Investigator: Michael Moncure, MD, FACS University of Kansas Medical Center
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Responsible Party: Michael Moncure, MD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02390440    
Other Study ID Numbers: CRA_IIT_Exparel_RibFractures
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Keywords provided by Michael Moncure, MD, University of Kansas Medical Center:
Pain management
Exparel
Rib fracture
Additional relevant MeSH terms:
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Rib Fractures
Fractures, Bone
Wounds and Injuries
Thoracic Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents