Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-Dose Steroid for Knee Arthroplasty

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03758170
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Sygehus Lillebaelt
Information provided by (Responsible Party):
Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre

Brief Summary:
The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on postoperative pain and postoperative inflammation.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Knee Osteoarthritis Perioperative/Postoperative Complications Surgery Drug: Dexamethasone Phase 4

Detailed Description:

This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting.

The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.

The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.

Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis on Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.

The two groups will be randomized and doubleblinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).

The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.

Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response. Also a series of blood tests determining the glucose-metabolism after the steroid-admission.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized doubleblinded controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.

The Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.

Primary Purpose: Treatment
Official Title: High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: High dose Dexamethasone
An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.
Drug: Dexamethasone
An intravenous bolus dose of dexamethasone given prior to surgery.
Other Name: Dexa-ratiopharm

Active Comparator: Medium dose Dexamethasone
An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.
Drug: Dexamethasone
An intravenous bolus dose of dexamethasone given prior to surgery.
Other Name: Dexa-ratiopharm




Primary Outcome Measures :
  1. Postoperative pain after 24 hours: VAS [ Time Frame: 24 hours ]

    The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.

    Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm.



Secondary Outcome Measures :
  1. Postoperative opioid usage [ Time Frame: 7 days ]
    The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.

  2. Postoperative antiemetics usage [ Time Frame: 7 days ]
    The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.

  3. The inflammatory response expressed by C-reactive protein(CRP). [ Time Frame: 2 days ]
    The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.

  4. Postoperative pain summed in the first 7 days [ Time Frame: 7 days ]
    Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.


Other Outcome Measures:
  1. Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward. [ Time Frame: 7 days. ]

    An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.

    The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.

    The outcome assesment will be descriptive.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 40 and 90.
  • Booked for unilateral knee-arthroplasty.
  • Is able to take part in the investigation(selfreported pain and nausea/vomiting)
  • Understands Danish or English, or has a translator available.
  • Signed written consent.

Exclusion Criteria:

  • Insulin-dependent diabetes melitus.
  • Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
  • Pregnancy/Breastfeeding
  • Allergies for the investigational drug.
  • Daily use of opioids.
  • A pain catastrophizing scale(PCS) score of >20.
  • A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

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): NCT03758170


Contacts
Layout table for location contacts
Contact: Niklas Ingemann Nielsen, MD 0045 28 29 34 88 Niklas.Ingemann.Nielsen@regionh.dk
Contact: Nicolai Bang Foss, Dr.Med. Nicolai.Bang.Foss@regionh.dk

Locations
Layout table for location information
Denmark
Hvidovre Hospital, Capital Region of Denmark. Recruiting
Hvidovre, Denmark, 2650
Contact: Niklas Ingemann Nielsen, MD.    0045 28 29 34 88    Niklas.Ingemann.Nielsen@regionh.dk   
Sub-Investigator: Henrik Husted, MD., Dr.Med.         
Vejle Sygehus Not yet recruiting
Vejle, Denmark, 7100
Contact: Claus Varnum, MD.       Claus.Varnum@rsyd.dk   
Principal Investigator: Claus Varnum, MD         
Sub-Investigator: Per Kjærsgaard-Andersen, MD         
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Sygehus Lillebaelt
Investigators
Layout table for investigator information
Study Director: Nicolai Bang Foss, Dr.med. Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.

Layout table for additonal information
Responsible Party: Niklas Ingemann Nielsen, Principal Investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03758170     History of Changes
Other Study ID Numbers: NBF_HK_01_2018
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre:
Knee Arthroplasty
Knee Replacement
Perioperative Medicine

Additional relevant MeSH terms:
Layout table for MeSH terms
Vomiting
Postoperative Nausea and Vomiting
Nausea
Osteoarthritis
Pain, Postoperative
Osteoarthritis, Knee
Postoperative Complications
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
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