High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2021-01-01

Brief Summary

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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 Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.

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Detailed Description

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

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 at 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 double blinded. 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.

Conditions

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Postoperative Pain Postoperative Nausea and Vomiting Knee Osteoarthritis Perioperative/Postoperative Complications Surgery Opioid Use Catastrophizing Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized double blinded controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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High dose Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

An intravenous bolus dose of dexamethasone given prior to surgery.

Medium dose Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

An intravenous bolus dose of dexamethasone given prior to surgery.

Interventions

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Dexamethasone

An intravenous bolus dose of dexamethasone given prior to surgery.

Intervention Type DRUG

Other Intervention Names

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Dexa-ratiopharm

Eligibility Criteria

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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.
* A daily use of 30 mg or more of morphine or morphine equivalents .
* A pain catastrophizing scale(PCS) score of \>20.

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.
* A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No