Back to resultsLidocaine Infusions for Rib Fractures (Lidocare)
Primary Purpose
Rib Fracture Multiple, Trauma Chest, Pain, Acute
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine infusion
Saline infusion
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fracture Multiple focused on measuring Lidocaine infusion
Eligibility 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
Sites / Locations
- Stanford Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Lidocaine
Arm Description
Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.
Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.
Outcomes
Primary Outcome Measures
Opioid pain medicine usage
Total opioid pain medicine usage
Secondary Outcome Measures
PCA requirements
Percentage of patients requiring PCA
Pain score
Average pain scores
Length of stay
Average length of stay in ICU and hospital
Respiratory failure
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
Mortality rate between two groups
Mobility
Highest level of mobility on hospital day #2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03571919
Brief Title
Lidocaine Infusions for Rib Fractures
Acronym
Lidocare
Official Title
Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to recruit during the Covid pandemic
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fracture Multiple, Trauma Chest, Pain, Acute
Keywords
Lidocaine infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.
Intervention Type
Drug
Intervention Name(s)
Lidocaine infusion
Intervention Description
Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
Intervention Type
Drug
Intervention Name(s)
Saline infusion
Intervention Description
Intravenous bolus of saline and then infusion
Primary Outcome Measure Information:
Title
Opioid pain medicine usage
Description
Total opioid pain medicine usage
Time Frame
Average per 24 hours
Secondary Outcome Measure Information:
Title
PCA requirements
Description
Percentage of patients requiring PCA
Time Frame
5 days
Title
Pain score
Description
Average pain scores
Time Frame
5 days
Title
Length of stay
Description
Average length of stay in ICU and hospital
Time Frame
5 days
Title
Respiratory failure
Description
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)
Time Frame
5 days
Title
Death
Description
Mortality rate between two groups
Time Frame
up to 30 days
Title
Mobility
Description
Highest level of mobility on hospital day #2
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Choi, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Y Lin, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lidocaine Infusions for Rib Fractures
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