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Completed

NCT Number: NCT02864602

IV Dexamethasone 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.

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Key information

Conditions

Anesthesia, Conduction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iv dexamethasone

Drug

An infusion of IV dexamethasone

Other names: Dexamethasone sodium phosphate injection USP

Primary outcomes

  1. The duration of sensory anesthesia and analgesia following median nerve block

    Time frame: This will be assessed for up to 12 hours following block

Secondary outcomes

  1. The duration of motor block following median nerve block

    Time frame: This will be assessed for up to 12 hours following block

  2. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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