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Status unknownNCT02760459Updated Oct 10, 2016

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

A Phase 4 interventional study of Dexamethasone and Normal saline solution in Osteoarthritis of the Knee, sponsored by Chiang Mai University. Status unknown at 1 site in Thailand. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-10-10.

Sponsored by Chiang Mai University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Osteoarthritis of the Knee
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • 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

Interventions

  • DrugDexamethasone
  • DrugNormal saline solution
06

What researchers measure

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

    Time frame: 12 weeks

Secondary outcomes

  1. Visual analogue scales for pain during a five-meter walk (0-100)

    Time frame: postoperatively at 24, 30, 48, 54, 72 hrs

  2. Visual analogue scales for pain during 45 degree active knee flexion (0-100)

    Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs

  3. Visual analogue scales for current pain at rest in a supine position (0-100)

    Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs

  4. 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)

    Time frame: postoperatively at 0-24, 24-48, 48-72 hrs

  5. Visual analogue scale values for nausea (0-100)

    Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs

  6. Opioid consumption (mg.)

    Time frame: during the first 0-24, 24-48, and 48-72 hrs

  7. Anti-emetic medicine consumption (mg.)

    Time frame: during the first 0-24, 24-48, and 48-72 hrs

  8. Maximum degree of active knee flexion

    Time frame: postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks

  9. Modified WOMAC scores for pain

    using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire

    Time frame: postoperatively at weeks 2 and 6

  10. Wound complications

    Time frame: evaluated postoperatively at weeks 2, 6 and 12

07

Study locations

1 of 1 sites recruiting
  • Department of Orthopedics, Chiang Mai University
    ChiangMai, 50200, Thailand
    Recruiting
08

References and documents

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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02760459
Lead sponsor
Chiang Mai University
Responsible party
Nitchanant Kitcharanant (MD, Chiang Mai University) — Principal investigator
First posted
May 3, 2016
Start date
Oct 2016
Primary completion
Jun 2017 (estimated)
Last update
Oct 10, 2016

Study contacts

Nitchanant Kitcharanant, MD
Contact
nk_win@hotmail.com
+66871071133
Nitchanant Kitcharanant, MD
principal investigator · Department of Orthopedics, Faculty of Medicine, Chiang Mai University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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