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Lidocaine Infusions for Rib Fractures (Lidocare)

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: NCT03571919
Recruitment Status : Unknown
Verified June 2018 by Michael Lin, Stanford University.
Recruitment status was:  Recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Lin, Stanford University

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE June 28, 2018
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
Opioid pain medicine usage [ Time Frame: Average per 24 hours ]
Total opioid pain medicine usage
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • PCA requirements [ Time Frame: 5 days ]
    Percentage of patients requiring PCA
  • Pain score [ Time Frame: 5 days ]
    Average pain scores
  • Length of stay [ Time Frame: 5 days ]
    Average length of stay in ICU and hospital
  • Respiratory failure [ Time Frame: 5 days ]
    Rates of pneumonia or other respiratory failure (pneumonia defined as (1) new pulmonary infiltrate on chest X-ray and (2) two of three of the following: (a) productive cough (b) WBC > 12,000 and (c) temperature > 38.0)
  • Death [ Time Frame: up to 30 days ]
    Mortality rate between two groups
  • Mobility [ Time Frame: 2 days ]
    Highest level of mobility on hospital day #2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine Infusions for Rib Fractures
Official Title  ICMJE Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
Brief Summary Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Immediate care providers (nurses, primary teams) will be blinded; however, lidocaine levels will be monitored by the acute pain service, a consulting team providing direct care to the patient, who will not be blinded.
Primary Purpose: Treatment
Condition  ICMJE
  • Rib Fracture Multiple
  • Trauma Chest
  • Pain, Acute
Intervention  ICMJE
  • Drug: Lidocaine infusion
    Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
  • Drug: Saline infusion
    Intravenous bolus of saline and then infusion
Study Arms  ICMJE
  • Placebo Comparator: Control
    Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.
    Intervention: Drug: Saline infusion
  • Active Comparator: Lidocaine
    Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.
    Intervention: Drug: Lidocaine infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
95
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients aged 18 or older with 2+ rib fractures or > 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI > 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure)

Exclusion Criteria:

Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS < 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR < 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic

Enrollment in other study that may affect the results of this study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03571919
Other Study ID Numbers  ICMJE 44300
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Lin, Stanford University
Study Sponsor  ICMJE Michael Lin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP