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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02760459
• Other study ID #: ORT-2558-03245
• Secondary ID: 054/2559
• Status: Recruiting
• Phase: Phase 4
• First received: May 1, 2016
• Last updated: October 7, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Chiang Mai University
• Contact: Nitchanant Kitcharanant, MD
• Phone: +66871071133
• Email: nk_win[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Dexamethasone

• Normal saline solution

Locations

Country	Name	City	State
Thailand	Department of Orthopedics, Chiang Mai University	ChiangMai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual analogue scales for pain during a five-meter walk (0-100)		postoperatively at 24, 30, 48, 54, 72 hrs	No
Secondary	Visual analogue scales for pain during 45 degree active knee flexion (0-100)		postoperatively at 6, 24, 30, 48, 54, 72 hrs	No
Secondary	Visual analogue scales for current pain at rest in a supine position (0-100)		postoperatively at 6, 24, 30, 48, 54, 72 hrs	No
Secondary	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	No
Secondary	Visual analogue scale values for nausea (0-100)		postoperatively at 6, 24, 30, 48, 54, 72 hrs	No
Secondary	Opioid consumption (mg.)		during the first 0-24, 24-48, and 48-72 hrs	No
Secondary	Anti-emetic medicine consumption (mg.)		during the first 0-24, 24-48, and 48-72 hrs	No
Secondary	Maximum degree of active knee flexion		postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks	No
Secondary	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	No
Secondary	Wound complications		evaluated postoperatively at weeks 2, 6 and 12	Yes