IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
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|ClinicalTrials.gov Identifier: NCT03855059|
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lower Limb Injury||Drug: Placebos Drug: Dexamethasone Sodium Phosphate||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The research pharmacist will randomize and prepare the necessary syringes for injection to look similar and have the same amount of solution as so the PI and anyone else does not know what is being given.|
|Primary Purpose:||Supportive Care|
|Official Title:||Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery|
|Actual Study Start Date :||June 5, 2019|
|Actual Primary Completion Date :||April 28, 2020|
|Actual Study Completion Date :||June 26, 2020|
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.
This will be a saline solution of given IV or perineural.
Other Name: 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 Name: Active treatment
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855059
|United States, Arizona|
|Banner University Medical Center|
|Tucson, Arizona, United States, 85719|
|Principal Investigator:||Peter R Lichtenthal, MD||University of Arizona|