Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.

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

Details

• Lead Sponsor: Chiang Mai University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Age > 40 years (45)

• Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)

• Undergoing elective, primary and unilateral total knee arthroplasty

• American Society of Anesthesiology (ASA) physical status class 1-3

• BMI < 40 kg/m2

Exclusion Criteria:

• History of active rheumatic diseases

• History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis

• History of previous surgery on the same knee

• History of adverse effects from medications to be used in this study

• Contraindication to spinal anesthesia

• History of psychiatric disorders or cognitive impairment

• Contraindication to corticosteroid agents

• Poorly controlled diabetes mellitus (HbA1C > 7.5)

• Poorly controlled hypertension

• History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease

• Hepatic insufficiency (Child-Pugh score > 5)

• Renal insufficiency (Creatinine clearance < 30 mL/min)

• History of cataracts or glaucoma or ocular hypertension

• History of steroid or immunosuppressive drug use within 6 months of surgery