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

Early Phase 1

Completed

• Conditions: Lower Limb Injury
• Interventions: Drug: Placebos; Drug: Dexamethasone Sodium Phosphate

• Registration Number: NCT03855059
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Study Start: 2019-06-05
• Primary Completion: 2020-04-28
• Study Completion: 2020-06-26
• Results First Submitted: 2021-03-15
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Results First Posted: 2021-07-21
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebos	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.
Dexamethasone Sodium Phosphate	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.

Primary Outcome Measures

Name	Time	Method
Analgesia Duration	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.

Trial Locations

Locations (1)

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States