NCT02864602

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 12, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

March 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

August 9, 2016

Last Update Submit

February 28, 2019

Conditions

Anesthesia, Conduction

Keywords

Regional anesthesiaAdjuvantDexamethasone

Outcome Measures

Primary Outcomes (1)

  • The duration of sensory anesthesia and analgesia following median nerve block

    This will be assessed for up to 12 hours following block

Secondary Outcomes (2)

  • The duration of motor block following median nerve block

    This will be assessed for up to 12 hours following block

  • Side effects related to nerve block or IV infusion of dexamethasone

    Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block

Study Arms (3)

Dexamethasone 2mg

EXPERIMENTAL

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

Dexamethasone 4mg

EXPERIMENTAL

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

Dexamethasone 8mg

EXPERIMENTAL

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

Interventions

IV dexamethasoneDRUG

An infusion of IV dexamethasone

Also known as: Dexamethasone sodium phosphate injection USP
Dexamethasone 2mgDexamethasone 4mgDexamethasone 8mg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 (normal healthy) volunteers.
  • years of age.
  • kg 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • Short A, El-Boghdadly K, Clarke H, Komaba T, Jin R, Chin KJ, Chan V. Effect of intravenous dexamethasone on the anaesthetic characteristics of peripheral nerve block: a double-blind, randomised controlled, dose-response volunteer study. Br J Anaesth. 2020 Jan;124(1):92-100. doi: 10.1016/j.bja.2019.08.029. Epub 2019 Nov 9.

    PMID: 31711605DERIVED

MeSH Terms

Interventions

Dexamethasonedexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

November 12, 2016

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

March 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations

CA(1)