IV Dexamethasone for Prolongation of Peripheral Nerve Block

University Health Network, Toronto

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Conduction

Treatments: Drug: IV dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02864602

15-5049-A

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups

Dexamethasone 2mg

Experimental group

Description:

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).

Treatment:

Drug: IV dexamethasone

Dexamethasone 4mg

Experimental group

Description:

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).

Treatment:

Drug: IV dexamethasone

Dexamethasone 8mg

Experimental group

Description:

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).

Treatment:

Drug: IV dexamethasone