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

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Dexamethasone; Drug: Normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02760459

ORT-2558-03245

054/2559 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.

Enrollment: 70 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.

Treatment:

Drug: Normal saline solution