IV Dexamethasone for Prolongation of Peripheral Nerve Block

Anesthesia, Conduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864602
• Other study ID #: 15-5049-A
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2016
• Est. completion date: February 20, 2018

Study information

• Verified date: January 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Conduction

Intervention

Drug:
• IV dexamethasone
An infusion of IV dexamethasone

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of sensory anesthesia and analgesia following median nerve block		This will be assessed for up to 12 hours following block
Secondary	The duration of motor block following median nerve block		This will be assessed for up to 12 hours following block
Secondary	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