Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Rib Fractures Clinical Trial

Official title:

A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04140396
• Other study ID #: 53087
• Status: Terminated
• Phase: Phase 4
• Start date: February 10, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Drug:
• Saline infusion
Normal saline infusion at 10mL/hour
• Lidocaine infusion
Lidocaine infusion at 1.0mg/kg/hr

Locations

Country	Name	City	State
United States	Stanford Healthcare	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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