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

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

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal saline solution

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • ChiangMai, Thailand, 50200
    • Recruiting
    • Department of Orthopedics, Chiang Mai University
    • Contact: Nitchanant Kitchatanant; Phone Number: +66871071133; Email: nk_win@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Dexamethasone
Placebo Comparator: Placebo; 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.	Drug: Normal saline solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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
Maximum degree of active knee flexion		postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
Modified WOMAC scores for pain	using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire	postoperatively at weeks 2 and 6
Wound complications		evaluated postoperatively at weeks 2, 6 and 12

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Nitchanant Kitcharanant, MD, Department of Orthopedics, Faculty of Medicine, Chiang Mai University

Publications and helpful links

General Publications

• 1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: May 1, 2016
• First Submitted That Met QC Criteria: May 1, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Knee; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: ORT-2558-03245; 054/2559 (Other Grant/Funding Number: Faculty of medicine, Chiangmai university fund)