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

NCT03855059 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 02182019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  24 - 48 hours

Study Arms (2)

Placebos

PLACEBO COMPARATOR

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

Dexamethasone Sodium Phosphate

ACTIVE COMPARATOR

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

Interventions

Placebos DRUG

This will be a saline solution of given IV or perineural.

Also known as: Non-active

Placebos

Dexamethasone Sodium Phosphate DRUG

This will be the active drug solution given IV or perineural.

Also known as: Active treatment

Dexamethasone Sodium Phosphate

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not scheduled to have a nerve block placed for post operative analgesia.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Leg Injuries

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Peter Lichtenthal, MD
• Organization: University of Arizona/Deptartment of Anesthesiology

plich@arizona.edu

5206267221

Study Officials

• Peter R Lichtenthal, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology

Model Details: Double blind study

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: June 5, 2019
• Primary Completion: April 28, 2020
• Study Completion: June 26, 2020
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)