Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Phase 4TerminatedNCT04140396

Stanford University1 enrolled

Overview

The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium. In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain. Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rib Fractures

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures Exclusion Criteria: * hemodynamically instability * mechanical ventilation * polytrauma (defined as bone or organ injury outside the thorax) * pregnancy * incarceration * local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block) * chronic opioid use.

Outcomes

Primary Outcomes

Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours

MME = morphine milligram equivalent

Time frame: After 24 hours of treatment

Secondary Outcomes

Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs

Time frame: After 48 hours of treatment

Pain Score

Pain scores at rest rated using the Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable

Time frame: Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion

Incentive Spirometry Volumes

An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.

Time frame: Pre-infusion baseline and 24 hours post-infusion

PIC Score

PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume (set by respiratory therapist), and strong cough.

Time frame: Time 0, 24 hours, 48 hour, and 72 hours.

Length of Hospital Stay

Number of hours stayed at the hospital from the day of operation till the day of discharge.

Time frame: 29 hours

Inflammatory Biomarkers

Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)

Time frame: Time 0, 24 hours, and 48 hour

Number of Pulmonary Complication Events

Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc.