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Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty (DEX-2-TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506789
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Naestved Hospital

Brief Summary:
Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Placebos Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial
Actual Study Start Date : September 14, 2018
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : June 7, 2020


Arm Intervention/treatment
Active Comparator: Treatment A:
24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
Drug: Dexamethasone
Dexamethasone 24 mg

Active Comparator: Treatment B:
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Drug: Dexamethasone
Dexamethasone 24 mg

Drug: Placebos
Isotonic saline

Placebo Comparator: Placebo
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
Drug: Placebos
Isotonic saline




Primary Outcome Measures :
  1. Cumulative usage of morphine 0-48 hours postoperatively [ Time Frame: 0-48 hours postoperatively ]

    Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively.

    Consumption in mg



Secondary Outcome Measures :
  1. VAS-pain scores (visual analogue scale (VAS)) [ Time Frame: 24 and 48 hours postoperatively ]
    • with active 45 degrees flexion of the knee (VAS) at 24 and 48 hours postoperatively
    • at rest at 24 and 48 hours postoperatively
    • highest score during 0-24 hours and 24-48 hours

  2. Adverse events, patient-reported [ Time Frame: 0-48 hours postoperatively ]
    Number of patients with one or more patient-reported adverse event in the intervention period


Other Outcome Measures:
  1. Number of patients with one or more serious adverse events (SAE) [ Time Frame: 90 days postoperatively ]
    Number of patients with one or more serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines), except "prolongation of hospitalisation"

  2. 90 days follow-up [ Time Frame: 90 days postoperatively ]
    Number of patients with need for medical attention and/or intervention including need for anti-biotics and/or re-operation

  3. Total need of i.v. morphine 0-24 hours postoperatively [ Time Frame: 0-24 hours postoperatively ]
    Consumption in mg

  4. Total need of oral morphine 24-48 hours postoperatively [ Time Frame: 24-48 hours postoperatively ]
    Consumption in mg

  5. VAS-pain scores (visual analogue scale (VAS)) [ Time Frame: 6, 24 and 48 hours postoperatively hours postoperatively ]
    • with active 45 degrees flexion of the knee (VAS) at 6 hours postoperatively
    • at rest at 6 postoperatively
    • average score during 0-24 hours and 24-48 hours

  6. Timed up and go (TUG) test at 24 and 48 hours including maximum pain during the TUG test. [ Time Frame: 24 and 48 hours postoperatively ]

    The timed up and go test is performed at 24 and 48 hours postoperatively. The participant will be placed on a chair, 3 meters from a line. After the command "Go" the participant will

    1. Stand up from the chair
    2. Walk to the line on the floor
    3. Turn
    4. Walk back to the chair
    5. Sit down again.

    The time will be measured from "Go" to the participant is sitting again.


  7. Adverse events, nausea [ Time Frame: 0-48 hours postoperatively ]

    Level of nausea at 6, 24 and 48 hours postoperatively

    Scale: none, mild, moderate, severe


  8. Adverse events, sedation [ Time Frame: 0-48 hours postoperatively ]

    Level of sedation at 6, 24 and 48 hours postoperatively

    Scale: none, mild, moderate, severe


  9. Adverse events, dizziness [ Time Frame: 0-48 hours postoperatively ]

    Level of dizziness at 6, 24 and 48 hours postoperatively

    Scale: none, mild, moderate, severe


  10. Adverse events, vomiting [ Time Frame: 0-48 hours postoperatively ]
    Number of vomiting episodes (0-48 hours) measured in the periods 0-24 and 24-48 hours postoperatively

  11. Consumption of antiemetics in the period 0-24 and 24-48 hours postoperatively [ Time Frame: 0-48 hours postoperatively ]
    Use of ondansetron and DHB (Dehydrobenzperidol)

  12. Quality of sleep 0-24 and 24-48 hours postoperatively [ Time Frame: 0-48 hours postoperatively ]
    Scale: very bad, fairly bad, fairly good, very good

  13. Level of fatigue at 24 and 48 hours postoperatively [ Time Frame: 24 and 48 hours postoperatively ]
    Scale: none, mild, moderate, severe

  14. NRS-pain scores 3-7 days postoperatively [ Time Frame: 3-7 days postoperatively ]
    Two daily NRS-scores: One in the morning and one in the evening

  15. Quality of sleep 3-7 days postoperatively [ Time Frame: 3-7 days postoperatively ]
    Scale: very bad, fairly bad, fairly good, very good

  16. Satisfaction with postoperative pain treatment after 7 days [ Time Frame: 7 days postoperatively ]
    Scale: very bad, fairly bad, fairly good, very good

  17. Proportion of participants with permanent use of opioids 90 days after surgery [ Time Frame: 90 days postoperatively ]
    Number of patients with prescripción for painkillers

  18. 90 days follow-up using EQ5D5L [ Time Frame: 90 days postoperatively ]
    Qualitative participant reported assessments using EQ5D5L (Questionaire - with one NRS (0-100))

  19. 90 days follow-up using Oxford-Knee-Score [ Time Frame: 90 days postoperatively ]
    Qualitative participant reported assessments using Oxford-Knee-Score (Questionaire, scale 12-60 points)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for unilateral, primary total knee arthroplasty
  • ASA 1-3
  • BMI ≥ 18.0 and ≤ 40.0
  • Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
  • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions

Exclusion Criteria:

  • Patients who cannot cooperate with the trial
  • Concomitant participation in another trial involving medication
  • Patients who cannot understand or speak Danish
  • Patients with allergy to medication used in the trial
  • Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
  • Patients with at daily use of systemic glucocorticoids
  • Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
  • Dysregulated diabetes (investigators judgement)
  • Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement

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): NCT03506789


Locations
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Denmark
Gildhøj Privathospital
Brøndbyvester, Denmark, 2605
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sjællands Universitetshospital, Køge
Køge, Denmark, 4600
Næstsved Sygehus
Næstved, Denmark, 4700
Odense Universitetshospital
Odense, Denmark, 5000
Sponsors and Collaborators
Naestved Hospital
Investigators
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Study Chair: Ole Mathiesen, MD, PhD, Assoc Prof Department of Anaesthesiology, Zealand University Hospital, Køge
Study Chair: Daniel Hägi-Pedersen, MD, PhD Department of Anaesthesiology, Næstved Hospital
Study Chair: Jørgen B Dahl, DMSc Department of Anaesthesiology, Bispebjerg Hospital
Principal Investigator: Kasper S Gasbjerg, MD Department of Anaesthesiology, Næstved Hospital
Study Chair: Troels H Lunn, DMSc Department of Anaesthesiology, Bispebjerg Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Naestved Hospital
ClinicalTrials.gov Identifier: NCT03506789    
Other Study ID Numbers: SM1-KAKG-2018
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will also be published anonymised according to ICIMEs (International Committee of Medical Journal Editors) guidelines
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
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