High-Dose Steroid for Knee Arthroplasty

NCT ID: NCT03758170

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2022-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Dexamethasone

An intravenous bolus dose of dexamethasone given prior to surgery.

Intervention Type: DRUG

Other Intervention Names

Dexa-ratiopharm

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sygehus Lillebaelt

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Niklas Ingemann Nielsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolai Bang Foss, Dr.med.

Role: STUDY_DIRECTOR

Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.

Locations

Hvidovre Hospital, Capital Region of Denmark.

Hvidovre, , Denmark

Vejle Sygehus

Vejle, , Denmark

Countries

Denmark

References

Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose dexamethasone in low pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2023 Mar;130(3):322-330. doi: 10.1016/j.bja.2022.10.038. Epub 2022 Dec 14.

Reference Type: DERIVED

PMID: 36526481 (View on PubMed)

Other Identifiers

NBF_HK_01_2018

Identifier Type: -

Identifier Source: org_study_id