Clinical trial NCT04140396: Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Official title: A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rib Fractures
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours
timeFrame: After 24 hours of treatment
Secondary outcomes:
measure: Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs
timeFrame: After 48 hours of treatment
measure: Pain Score
timeFrame: Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion
measure: Incentive Spirometry Volumes
timeFrame: Pre-infusion baseline and 24 hours post-infusion
measure: PIC Score
timeFrame: Time 0, 24 hours, 48 hour, and 72 hours.
measure: Length of Hospital Stay
timeFrame: 29 hours
measure: Inflammatory Biomarkers
timeFrame: Time 0, 24 hours, and 48 hour
measure: Number of Pulmonary Complication Events
timeFrame: 29 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
Study officials:
References:
citation: Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
citation: Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
citation: Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.
citation: Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.