Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Phase 4

Terminated

• Conditions: Rib Fractures
• Interventions: Drug: Saline infusion; Drug: Lidocaine infusion

• Registration Number: NCT04140396
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2020-02-10
• Primary Completion: 2020-11-09
• Study Completion: 2020-11-09
• Results First Submitted: 2023-09-26
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Saline infusion	Participants will receive placebo infusion consisting of normal saline
Active Comparator	Lidocaine infusion	Participants will receive a lidocaine infusion

Primary Outcome Measures

Name	Time	Method
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours	After 24 hours of treatment	MME = morphine milligram equivalent

Secondary Outcome Measures

Name	Time	Method
Number of Pulmonary Complication Events	29 hours	Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc.
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs	After 48 hours of treatment
Pain Score	Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion	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
PIC Score	Time 0, 24 hours, 48 hour, and 72 hours.	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.
Incentive Spirometry Volumes	Pre-infusion baseline and 24 hours post-infusion	An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
Length of Hospital Stay	29 hours	Number of hours stayed at the hospital from the day of operation till the day of discharge.
Inflammatory Biomarkers	Time 0, 24 hours, and 48 hour	Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)

Trial Locations

Locations (1)

Stanford Healthcare; 🇺🇸 Stanford, California, United States