Clinical trial NCT03758170: High-Dose Steroid for Knee Arthroplasty
Official title: High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Knee Osteoarthritis
Perioperative/Postoperative Complications
Surgery
Keywords: Knee Arthroplasty
Knee Replacement
Perioperative Medicine
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Sygehus Lillebaelt
First posted: 2018-11-29
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized doubleblinded controlled trial.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Postoperative pain after 24 hours: VAS
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative opioid usage
timeFrame: 7 days
measure: Postoperative antiemetics usage
timeFrame: 7 days
measure: The inflammatory response expressed by C-reactive protein(CRP).
timeFrame: 2 days
measure: Postoperative pain summed in the first 7 days
timeFrame: 7 days
Other outcomes:
measure: Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.
timeFrame: 7 days.
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Capital Region of Denmark.
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.
name: Nicolai Bang Foss, Dr.med.
role: STUDY_DIRECTOR
References: