Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Phase: EARLY_PHASE1
Conditions: Lower Limb Injury
Sponsor: University of Arizona

 
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.