IV Dexamethasone for Prolongation of Peripheral Nerve Block

• Status: Completed
• Trial end date: 2018-02-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.