Exparel for Pain Control During Care of Rib Fractures

January 17, 2017 updated by: Michael Moncure, MD

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Liposomal Bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Treatment to Hour 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 10 days, average length of stay expected to be 3 days
opioid use
Time Frame: Change from Treatment to Hour 72
Change from Treatment to Hour 72
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.
Change from Treatment to Hour 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Moncure, MD

Investigators

  • Principal Investigator: Michael Moncure, MD, FACS, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRA_IIT_Exparel_RibFractures

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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