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

Primary Purpose

Lower Limb Injury

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebos
Dexamethasone Sodium Phosphate
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lower Limb Injury

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebos

Dexamethasone Sodium Phosphate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Analgesia Duration
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2019
Last Updated
June 30, 2021
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03855059
Brief Title
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Official Title
Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double blind study
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dexamethasone Sodium Phosphate
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Non-active
Intervention Description
This will be a saline solution of given IV or perineural.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate
Other Intervention Name(s)
Active treatment
Intervention Description
This will be the active drug solution given IV or perineural.
Primary Outcome Measure Information:
Title
Analgesia Duration
Description
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.
Time Frame
24 - 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R Lichtenthal, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States

12. IPD Sharing Statement

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

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