CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 50 enrolled
Drug / intervention
Placebos +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03855059
NCT03855059Early Ph 1Completed
CompareCT.gov

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

University of Arizona·interventional·Posted Feb 26, 2019·Updated Jul 21, 2021

In Brief

A Early Phase 1 clinical trial evaluating Placebos and Dexamethasone Sodium Phosphate for Lower Limb Injury. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Limb Injury
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 26, 2019
Enrollment StartJun 5, 2019
Primary CompletionApr 28, 2020
Study CompletionJun 26, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.4 years ago

Interventions

Placebosdrug

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

Dexamethasone Sodium Phosphatedrug

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