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WithdrawnNCT02390440Updated Jan 19, 2017

Exparel for Pain Control During Care of Rib Fractures

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 Withdrawn at 1 site in United States.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

Why this study was withdrawn
Did not obtain an IND.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Pain

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Keywords

  • Pain management
  • Exparel
  • Rib fracture
03

In context

Rib Fractures

131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.

Browse Rib Fractures studies →

Lead sponsor

This is the only study on the registry with Michael Moncure, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    EXPAREL

    single dose, 266mg (20mL) of EXPAREL injected to slowly infiltrate the soft tissue around the site of fracture

    Drug: EXPAREL

Interventions

  • DrugEXPAREL

    Also known as: Liposomal Bupivicaine

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. opioid use

    Time frame: Change from Treatment to Hour 72

  3. 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

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02390440
Lead sponsor
Michael Moncure, MD
Responsible party
Michael Moncure, MD (Professor, University of Kansas Medical Center) — Sponsor-investigator
First posted
Mar 17, 2015
Start date
Apr 2015
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 19, 2017

Study contacts

Michael Moncure, MD, FACS
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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