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

Lower Limb Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855059
• Other study ID #: 02182019
• Status: Completed
• Phase: Early Phase 1
• Start date: June 5, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 26, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Injuries
• Lower Limb Injury

Intervention

Drug:
• Placebos
This will be a saline solution of given IV or perineural.
• Dexamethasone Sodium Phosphate
This will be the active drug solution given IV or perineural.

Locations

Country	Name	City	State
United States	Banner University Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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