High-Dose Steroid for Knee Arthroplasty

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting; Postoperative Pain; Surgery; Perioperative/Postoperative Complications; Knee Osteoarthritis
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03758170
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2019-01-29
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose Dexamethasone	Dexamethasone	An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.
Medium dose Dexamethasone	Dexamethasone	An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative pain after 24 hours: VAS	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

Name	Time	Method
Postoperative opioid usage	7 days	The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.
Postoperative pain summed in the first 7 days	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.
Postoperative antiemetics usage	7 days	The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.
The inflammatory response expressed by C-reactive protein(CRP).	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.

Trial Locations

Locations (2)

Hvidovre Hospital, Capital Region of Denmark.; 🇩🇰 Hvidovre, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark