Lidocaine Infusions for Rib Fractures

Phase 4

Withdrawn

• Conditions: Pain, Acute; Rib Fracture Multiple; Trauma Chest
• Interventions: Drug: Lidocaine infusion; Drug: Saline infusion

• Registration Number: NCT03571919
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine infusion	Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours.
Control	Saline infusion	Will receive normal saline bolus and infusion and have sham lab draws every 8 hours.

Primary Outcome Measures

Name	Time	Method
Opioid pain medicine usage	Average per 24 hours	Total opioid pain medicine usage

Secondary Outcome Measures

Name	Time	Method
Pain score	5 days	Average pain scores
PCA requirements	5 days	Percentage of patients requiring PCA
Length of stay	5 days	Average length of stay in ICU and hospital
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)
Death	up to 30 days	Mortality rate between two groups
Mobility	2 days	Highest level of mobility on hospital day #2

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States