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

• 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: University of Arizona
• Information provided by (Responsible Party): Peter R. Lichtenthal, MD, University of Arizona

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Arizona

Banner University Medical Center

Tucson, Arizona, United States, 85719

Sponsors and Collaborators

University of Arizona

Investigators

• Principal Investigator: Peter R Lichtenthal, MD; University of Arizona

  Study Documents (Full-Text)

Documents provided by Peter R. Lichtenthal, MD, University of Arizona:

Study Protocol and Statistical Analysis Plan  [PDF] May 16, 2019

More Information

• 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
• Results First Posted: July 21, 2021
• Last Update Posted: July 21, 2021
• Last Verified: June 2021

• 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:

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