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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

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.

Condition or disease Intervention/treatment Phase
Rib Fracture Multiple Trauma Chest Pain, Acute Drug: Lidocaine infusion Drug: Saline infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
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
Official Title: Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.
Drug: Saline infusion
Intravenous bolus of saline and then infusion

Active Comparator: Lidocaine
Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.
Drug: Lidocaine infusion
Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr




Primary Outcome Measures :
  1. Opioid pain medicine usage [ Time Frame: Average per 24 hours ]
    Total opioid pain medicine usage


Secondary Outcome Measures :
  1. PCA requirements [ Time Frame: 5 days ]
    Percentage of patients requiring PCA

  2. Pain score [ Time Frame: 5 days ]
    Average pain scores

  3. Length of stay [ Time Frame: 5 days ]
    Average length of stay in ICU and hospital

  4. 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)

  5. Death [ Time Frame: up to 30 days ]
    Mortality rate between two groups

  6. Mobility [ Time Frame: 2 days ]
    Highest level of mobility on hospital day #2



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 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


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): NCT03571919


Contacts
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Contact: Michael Y Lin, MD 4158431186 mikelin@stanford.edu
Contact: Shikha Kapil, MD skapil@stanford.edu

Locations
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United States, California
Stanford Hospital and Clinics Recruiting
Palo Alto, California, United States, 94304
Contact: Michael Y Lin, MD    415-843-1186    michaelylin@gmail.com   
Sponsors and Collaborators
Michael Lin
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Responsible Party: Michael Lin, MD, Stanford University
ClinicalTrials.gov Identifier: NCT03571919    
Other Study ID Numbers: 44300
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael Lin, Stanford University:
Lidocaine infusion
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Rib Fractures
Fractures, Multiple
Wounds and Injuries
Thoracic Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Multiple Trauma
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action