We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855059
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Peter R. Lichtenthal, MD, University of Arizona

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 26, 2019
Results First Submitted Date  ICMJE March 15, 2021
Results First Posted Date  ICMJE July 21, 2021
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE June 5, 2019
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Official Title  ICMJE Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
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
Condition  ICMJE Lower Limb Injury
Intervention  ICMJE
  • Drug: Placebos
    This will be a saline solution of given IV or perineural.
    Other Name: Non-active
  • Drug: Dexamethasone Sodium Phosphate
    This will be the active drug solution given IV or perineural.
    Other Name: Active treatment
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebos
  • 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.
    Intervention: Drug: Dexamethasone Sodium Phosphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2021)
50
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)
100
Actual Study Completion Date  ICMJE June 26, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03855059
Other Study ID Numbers  ICMJE 02182019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Peter R. Lichtenthal, MD, University of Arizona
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Arizona
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter R Lichtenthal, MD University of Arizona
PRS Account University of Arizona
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP