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Completed

NCT Number: NCT03855059

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.

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Key information

Conditions

Lower Limb Injury Leg Injuries Wounds and Injuries

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Banner University Medical Center

Tucson, Arizona, 85719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebos

Drug

This will be a saline solution of given IV or perineural.

Other names: Non-active

Dexamethasone sodium phosphate

Drug

This will be the active drug solution given IV or perineural.

Other names: Active treatment

Primary outcomes

  1. Analgesia Duration

    Time frame: 24 - 48 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2019
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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