High-Dose Steroid for Knee Arthroplasty

Copenhagen University Hospital, Hvidovre

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Surgery; Perioperative/Postoperative Complications; Postoperative Nausea and Vomiting; Knee Osteoarthritis

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03758170

NBF_HK_01_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

High dose Dexamethasone

Experimental group

Description:

An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.

Treatment:

Drug: Dexamethasone

Medium dose Dexamethasone

Active Comparator group

Description:

An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.

Treatment:

Drug: Dexamethasone