Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Comparator Participants will receive placebo infusion consisting of normal saline |
Drug: Saline infusion
Normal saline infusion at 10mL/hour
|
| Active Comparator: Active Comparator Participants will receive a lidocaine infusion |
Drug: Lidocaine infusion
Lidocaine infusion at 1.0mg/kg/hr
|
Outcome Measures
Primary Outcome Measures
- OME consumption at 24 hours [After 24 hours of treatment]
oral morphine equivalent consumption at 24 hours of treatment
Secondary Outcome Measures
- OME at 48 hrs [After 48 hours of treatment]
oral morphine equivalent consumption at 48 hours of treatment
- Pain Score [Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.]
Pain scores at rest and with cough and deep inspiration. Will use Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable
- Incentive spirometry volumes [Time 0, 24 hours, 48 hour, and 72 hours.]
An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
- 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.
- Length of hospital stay [Up to 10 days]
We will record the number of days stayed at the hospital from the day of operation till the day of discharge (from 0-10, or 10+)
- Inflammatory biomarkers [Time 0, 24 hours, and 48 hour]
Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
- Rates of pulmonary complications [Will be assessed up to 72 hours.]
We will look at the occurrence of things like ARDS, pneumonia, aspiration, empyema, etc
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Healthcare | Stanford | California | United States | 94304 |
Sponsors and Collaborators
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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.
- Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. Review.
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