High-Dose Steroid for Knee Arthroplasty

Surgery Clinical Trial

Official title:

High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758170
• Other study ID #: NBF_HK_01_2018
• Status: Completed
• Phase: Phase 4
• Start date: January 29, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee
• Perioperative/Postoperative Complications
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Surgery
• Vomiting

Intervention

Drug:
• Dexamethasone
An intravenous bolus dose of dexamethasone given prior to surgery.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Capital Region of Denmark.	Hvidovre
Denmark	Vejle Sygehus	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.	An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.; The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.; The outcome assesment will be descriptive.	7 days.
Primary	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	Postoperative opioid usage	The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.	7 days
Secondary	Postoperative antiemetics usage	The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.	7 days
Secondary	The inflammatory response expressed by C-reactive protein(CRP).	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.	2 days
Secondary	Postoperative pain summed in the first 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.	7 days