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

Phase 4

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Normal saline solution; Drug: Dexamethasone

• Registration Number: NCT02760459
• Lead Sponsor: Chiang Mai University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-01
• Study First Posted: 2016-05-03
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline solution	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.
Dexamethasone	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Modified WOMAC scores for pain at 12 weeks postoperative	12 weeks	using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire

Secondary Outcome Measures

Name	Time	Method
Visual analogue scales for pain during a five-meter walk (0-100)	postoperatively at 24, 30, 48, 54, 72 hrs
Visual analogue scales for pain during 45 degree active knee flexion (0-100)	postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scales for current pain at rest in a supine position (0-100)	postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scale values for nausea (0-100)	postoperatively at 6, 24, 30, 48, 54, 72 hrs
Opioid consumption (mg.)	during the first 0-24, 24-48, and 48-72 hrs
Anti-emetic medicine consumption (mg.)	during the first 0-24, 24-48, and 48-72 hrs
Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)	postoperatively at 0-24, 24-48, 48-72 hrs
Maximum degree of active knee flexion	postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
Modified WOMAC scores for pain	postoperatively at weeks 2 and 6	using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Wound complications	evaluated postoperatively at weeks 2, 6 and 12

Trial Locations

Locations (1)

Department of Orthopedics, Chiang Mai University; 🇹🇭 ChiangMai, Thailand