Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery

• Status: Completed
• Trial end date: 2017-01-12
• Target enrollment: 0
• Participant gender: All

Summary

In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery

• Including rotator cuff repair

• Stabilization procedures

• Acromioplasty

• Debridement and distal clavicle excision

Exclusion Criteria:

• Patient refusal, diabetes

• Pregnancy

• Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist

• Sensitivity to local anesthetics or dexamethasone

• Severe chronic obstructive pulmonary disease

• Contralateral vocal cord paralysis

• Contralateral diaphragmatic paralysis

• Surgical limb brachial plexus neuropathy

• Interscalene block site infection

• Systemic glucocorticoids in the last 2 weeks

• Epidural or intraarticular steroid injection in the past 3 months

• Chronic opioid use defined as daily use for the last two weeks

• International normalized ratio (INR) > 1.5

• Active peptic ulcer disease

• End-stage renal disease

• Cirrhotic liver disease

• Previous participation in the study.