High-Dose Steroid for Knee Arthroplasty

NCT03758170 | Completed Phase 4 DMC

• 1 other identifier: NBF_HK_01_2018
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Knee Arthroplasty; Knee Replacement; Perioperative Medicine

Outcome Measures

Primary Outcomes (1)

• Postoperative pain after 24 hours: VAS

  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.

  24 hours

Secondary Outcomes (4)

• Postoperative opioid usage

  7 days

• Postoperative antiemetics usage

  7 days

• The inflammatory response expressed by C-reactive protein(CRP).

  2 days

• Postoperative pain summed in the first 7 days

  7 days

Other Outcomes (1)

• Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.

  7 days.

Study Arms (2)

High dose Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Medium dose Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

An intravenous bolus dose of dexamethasone given prior to surgery.

Also known as: Dexa-ratiopharm

High dose Dexamethasone; Medium dose Dexamethasone

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Sygehus Lillebaelt: collaborator

Study Sites (2)

Hvidovre Hospital, Capital Region of Denmark.

Hvidovre, 2650, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36526481 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Osteoarthritis, Knee; Postoperative Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nicolai Bang Foss, Dr.med.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized doubleblinded controlled trial.

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 29, 2018
• Study Start: January 29, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From 1 year after last included patient, and onto 4 years after end of trial.
• Access Criteria: Upon reasonable request to the corresponding author

Locations

DK (2)