Pain, Acute, Rib Fracture Multiple, Trauma Chest
Conditions
Keywords
Lidocaine infusion
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.
Interventions
DRUGLidocaine infusion
Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
DRUGSaline infusion
Intravenous bolus of saline and then infusion
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid pain medicine usage | Average per 24 hours | Total opioid pain medicine usage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 5 days | Average pain scores |
| Length of stay | 5 days | Average length of stay in ICU and hospital |
| PCA requirements | 5 days | Percentage of patients requiring PCA |
| Death | up to 30 days | Mortality rate between two groups |
| Mobility | 2 days | Highest level of mobility on hospital day #2 |
| Respiratory failure | 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) |
Countries
United States
Outcome results
None listed