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

NCT02760459 | Unknown Phase 4

• 2 other identifiers: ORT-2558-03245054/2559
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Interventions

Dexamethasone DRUG

Dexamethasone

Normal saline solution DRUG

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Orthopedics, Chiang Mai University

Chiang Mai, ChiangMai, 50200, Thailand

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.

  PMID: 39702151 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nitchanant Kitcharanant, MD

  Department of Orthopedics, Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitchanant Kitcharanant, MD

CONTACT

+66871071133; nk_win@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 3, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

TH (1)