Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery

• Status: Completed
• Trial end date: 2018-10-13
• Target enrollment: 0
• Participant gender: All

Summary

In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.

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

Details

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

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, dexamethasone or dexmedetomidine

• 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

• Active peptic ulcer disease

• End-stage renal disease

• Cirrhotic liver disease

• Ventricular dysfunction

• Advanced heart block

• Previous participation in the study.