Clinical trial NCT03855059
Conditions: Lower Limb Injury
Sponsor: University of Arizona
Start date: 2019-06-05; Completion date: 2020-06-26
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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:
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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Placebos intervention 2: Dexamethasone Sodium Phosphate
Intervention descriptions: intervention 1: This will be a saline solution of given IV or perineural. intervention 2: This will be the active drug solution given IV or perineural.

Protocol documents:
Prot_SAP_000.pdf: 
 
May 16, 2019 
 
IV Steroids Versus 
Steroids Included in 
Block for Orthopedic 
Lower Limb Surgery 
NCT 03855059 
PETER LICHTENTHAL 


 
 
Introduction: 
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, we have not noticed this in children.  The 
objective of this study is to examine this in young patients.  We will blindly give the steroid either 
in the IV or in the block solution (perineural).  This is a prospective double blind study. 
 
Inclusion: 
• Male and female subject’s ages 5 – 25 years of age 
• Scheduled for lower limb orthopedic procedures 
• ASA class I - III 
 
Groups: 
• Steroids in the IV group 
25 – 50 
• Steroids in block group  
25 – 50 
 
Subjects will be randomized to either group; the syringes will be mixed by the pharmacy and 
blinded to the study personnel. 
 
Methods:    
Subjects will be anesthetized as standard of care, once anesthetized and IV catheters are placed, 
subjects will be given 0.1 – 0.15 mg/kg dexamethasone or placebo IV, nerve block will be 
administered perineural with, Mepivicaine with epinephrine 0.25%, 4.0 mg/kg plus 0.1 – 0.15 
mg/kg dexamethasone or placebo. 
 
Syringe Options Randomized: 
1. Steroids given Intravenously 
• 20 cc - Nerve block solution, Mepivicaine with epinephrine 0.25% (4.0 mg/kg) + 
placebo.  
• 5 cc - steroids given IV (0.1 – 0.15 mg/kg) 
 
2. Steroids given in nerve block solution 
• 20 cc -  local (4.0 mg/kg)  + steroids (0.1 – 0.15 mg/kg) 
• 5 cc - Placebo IV 
 
We will record the time of block, IV injection and the surgery time and medications given in 
recovery.  A phone call will made to the patient or patient’s parent at 24 hours and again at 48 
hours if needed to ask how long they had pain relief. 
 
 
 
 


 
 
 
STATISTICAL ANALYSIS PLAN: 
Statistical analyses comparing the two groups were conducted with commercially available 
software (SigmaPlot 14, Systat Software, Inc., San Jose, CA, USA)  Previous preliminary work with 
this treatment para STATISTICAL ANALYSIS PLANdigm demonstrated that n≥ 23 per group would 
be required to detect a significant difference induration of analgesia with a statistical power of 
0.8 with significance of P<0.05.  Categorical data were assessed with chi-squared analyses 
whereas continuous data were compared with unpaired, two-tailed Student’s t-tests.  Data were 
presented as raw values or mean±SD.  P<0.05 was considered significant.