Lidocaine Infusions for Rib Fractures (Lidocare)

Stanford University

Status and phase: Withdrawn; Phase 4

Conditions: Rib Fracture Multiple; Trauma Chest; Pain, Acute

Treatments: Drug: Lidocaine infusion; Drug: Saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03571919

44300

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.

Treatment:

Drug: Saline infusion

Lidocaine

Active Comparator group

Description:

Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.

Treatment:

Drug: Lidocaine infusion