IV Dexamethasone for Prolongation of Peripheral Nerve Block

February 28, 2019 updated by: University Health Network, Toronto

A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block

This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 (normal healthy) volunteers.
  • 18 - 50 years of age.
  • 60 - 100kg weight.
  • English speaking.
  • Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
  • Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.

Exclusion Criteria:

  • Medical disorders (including bleeding disorders).
  • Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
  • Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
  • Contraindication to regional anesthetic block.
  • Inability to provide informed consent.
  • Baseline abnormality of hand sensation or motor function.
  • Pregnancy / breast feeding.
  • Individuals with mental health disorders (for example bipolar disorder or depression).
  • Individuals with cataracts or glaucoma.
  • Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone 2mg
The experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Names:
  • Dexamethasone sodium phosphate injection USP
Experimental: Dexamethasone 4mg
The experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Names:
  • Dexamethasone sodium phosphate injection USP
Experimental: Dexamethasone 8mg
The experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Names:
  • Dexamethasone sodium phosphate injection USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The duration of sensory anesthesia and analgesia following median nerve block
Time Frame: This will be assessed for up to 12 hours following block
This will be assessed for up to 12 hours following block

Secondary Outcome Measures

Outcome Measure
Time Frame
The duration of motor block following median nerve block
Time Frame: This will be assessed for up to 12 hours following block
This will be assessed for up to 12 hours following block
Side effects related to nerve block or IV infusion of dexamethasone
Time Frame: Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block
Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2016

Primary Completion (Actual)

February 20, 2018

Study Completion (Actual)

February 20, 2018

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-5049-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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