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

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Injury
• Intervention / Treatment: Drug: Placebos; Drug: Dexamethasone Sodium Phosphate

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebos; 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; This will be a saline solution of given IV or perineural.; Other Names: Non-active
Active Comparator: Dexamethasone Sodium Phosphate; 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; This will be the active drug solution given IV or perineural.; Other Names: Active treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Peter R Lichtenthal, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: 02182019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No