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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

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.

Condition or disease Intervention/treatment Phase
Lower Limb Injury Drug: Placebos Drug: Dexamethasone Sodium Phosphate Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebos
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Arizona
Banner University Medical Center
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Peter R Lichtenthal, MD University of Arizona
  Study Documents (Full-Text)

Documents provided by Peter R. Lichtenthal, MD, University of Arizona:
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Responsible Party: Peter R. Lichtenthal, MD, Professor, Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier: NCT03855059    
Other Study ID Numbers: 02182019
First Posted: February 26, 2019    Key Record Dates
Results First Posted: July 21, 2021
Last Update Posted: July 21, 2021
Last Verified: June 2021

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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
Additional relevant MeSH terms:
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Leg Injuries
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action