A Phase 4 interventional study of Lidocaine infusion and Saline infusion in Rib Fracture Multiple, Trauma Chest and Pain, Acute, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-28.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
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.
72 studies on the registry are indexed under Thoracic Injuries; 18 are open to participants now.
Browse Thoracic Injuries studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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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, > 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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.
Drug: Saline infusion
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
Intravenous bolus of saline and then infusion
Opioid pain medicine usage
Total opioid pain medicine usage
Time frame: Average per 24 hours
PCA requirements
Percentage of patients requiring PCA
Time frame: 5 days
Pain score
Average pain scores
Time frame: 5 days
Length of stay
Average length of stay in ICU and hospital
Time frame: 5 days
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)
Time frame: 5 days
Death
Mortality rate between two groups
Time frame: up to 30 days
Mobility
Highest level of mobility on hospital day #2
Time frame: 2 days
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine