IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery

Study Overview
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Brief Summary
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IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.

Detailed Description
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The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to receive either steroid given IV or with the nerve block, the subject is anesthetized and the subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local anesthetic plus placebo or steroid in the nerve block, the block will be placed under ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 - 0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects will be called by the study PI after 24 hours to determine the time of duration and again at 48 hours if needed. This is a randomized, double blind study, neither the subject or the anesthesiologist giving the injection will know what is being given. The medications will be prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by the research pharmacist.

Official Title
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Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery

Conditions
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Lower Limb Injury

Intervention / Treatment
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* Drug: Placebos
* Drug: Dexamethasone Sodium Phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to have a lower limb Orthopedic surgical procedure. Scheduled to have a nerve block placed for post operative analgesia. American Society of Anesthesiologist (ASA) Class I - III. Exclusion Criteria: Not scheduled to have a nerve block placed for post operative analgesia.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebos<br>Depending on the randomization, this group will receive a saline solution either in the IV catheter or the saline solution will be given perineural with the Mepivicaine nerve block solution. | Drug: Placebos<br>* This will be a saline solution of given IV or perineural.<br>* Other names: Non-active;|
| Active Comparator: Dexamethasone Sodium Phosphate<br>Depending on the randomization, this group will receive dexamethasone 0.1 - 0.15 mg/kg, either in the IV catheter or the dexamethasone, 0.1 - 0.15 mg/kg will be given perineural with the Mepivicaine nerve block solution. | Drug: Dexamethasone Sodium Phosphate<br>* This will be the active drug solution given IV or perineural.<br>* Other names: Active treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Duration | The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia. | 24 - 48 hours |