High-Dose Steroid for Knee Arthroplasty

March 9, 2022 updated by: Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre

High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital, Capital Region of Denmark.
      • Vejle, Denmark, 7100
        • Vejle Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Dexa-ratiopharm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid usage
Time Frame: 7 days
The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.
7 days
Postoperative antiemetics usage
Time Frame: 7 days
The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.
7 days
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.
2 days
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.
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

Sygehus Lillebaelt

Investigators

  • Study Director: Nicolai Bang Foss, Dr.med., Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2019

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (ACTUAL)

November 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBF_HK_01_2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request

IPD Sharing Time Frame

From 1 year after last included patient, and onto 4 years after end of trial.

IPD Sharing Access Criteria

Upon reasonable request to the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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