Lidocaine Infusions for Rib Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Rib Fracture Multiple Trauma Chest Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Saline infusion

Intervention Type DRUG

Intravenous bolus of saline and then infusion

Lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine infusion

Intervention Type DRUG

Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr

Interventions

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Lidocaine infusion

Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr

Intervention Type DRUG

Saline infusion

Intravenous bolus of saline and then infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No