Clinical trial NCT02760459: Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Modified WOMAC scores for pain at 12 weeks postoperative
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual analogue scales for pain during a five-meter walk (0-100)
timeFrame: postoperatively at 24, 30, 48, 54, 72 hrs
measure: Visual analogue scales for pain during 45 degree active knee flexion (0-100)
timeFrame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
measure: Visual analogue scales for current pain at rest in a supine position (0-100)
timeFrame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
measure: 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)
timeFrame: postoperatively at 0-24, 24-48, 48-72 hrs
measure: Visual analogue scale values for nausea (0-100)
timeFrame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
measure: Opioid consumption (mg.)
timeFrame: during the first 0-24, 24-48, and 48-72 hrs
measure: Anti-emetic medicine consumption (mg.)
timeFrame: during the first 0-24, 24-48, and 48-72 hrs
measure: Maximum degree of active knee flexion
timeFrame: postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
measure: Modified WOMAC scores for pain
timeFrame: postoperatively at weeks 2 and 6
measure: Wound complications
timeFrame: evaluated postoperatively at weeks 2, 6 and 12
Other outcomes:
Locations:
city: ChiangMai
country: Thailand
facility: Department of Orthopedics, Chiang Mai University
Study officials:
affiliation: Department of Orthopedics, Faculty of Medicine, Chiang Mai University
name: Nitchanant Kitcharanant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.