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

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ClinicalTrials.gov Identifier: NCT02760459
Recruitment Status : Unknown
Verified October 2016 by Nitchanant Kitcharanant, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Nitchanant Kitcharanant, Chiang Mai University

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Dexamethasone Drug: Normal saline solution Phase 4

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : June 2017


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



Primary Outcome Measures :
  1. Modified WOMAC scores for pain at 12 weeks postoperative [ Time Frame: 12 weeks ]
    using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire


Secondary Outcome Measures :
  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 [ Time Frame: postoperatively at weeks 2 and 6 ]
    using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire

  10. Wound complications [ Time Frame: evaluated postoperatively at weeks 2, 6 and 12 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760459


Contacts
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Contact: Nitchanant Kitcharanant, MD +66871071133 nk_win@hotmail.com

Locations
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Thailand
Department of Orthopedics, Chiang Mai University Recruiting
ChiangMai, Thailand, 50200
Contact: Nitchanant Kitchatanant    +66871071133    nk_win@hotmail.com   
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Nitchanant Kitcharanant, MD Department of Orthopedics, Faculty of Medicine, Chiang Mai University

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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Responsible Party: Nitchanant Kitcharanant, MD, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02760459     History of Changes
Other Study ID Numbers: ORT-2558-03245
054/2559 ( Other Grant/Funding Number: Faculty of medicine, Chiangmai university fund )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action