RecruitingPhase 4NCT05023369

This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time

Periarticular Administration of Dexamethasone to Improve Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Hip Arthroplasty - A Randomized Trial

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

110 participants

Start Date

Dec 10, 2021

Study Type

INTERVENTIONAL

Conditions

Femoral Neck Fractures

Summary

The investigators are going to evaluate if periarticular corticosteroid injection during endoprothesis implantation can lead to any advantage to the patients, namely if it can reduce post-operative pain, lenght and cost of hospitalisation, use of analgesics drugs.

Eligibility

Min Age: 50 YearsMax Age: 90 Years

Inclusion Criteria5

Patients undergoing unilateral cemented hip endoprosthesis for femoral neck fracture
Patients aged 50-90 years old
Patients with a BMI \>18.5 and \<35
Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
Informed Consent as documented by signature

Exclusion Criteria13

Contraindications to steroids
Revision endoprosthesis
Active steroid or immunosuppressive therapy in the last 30 days before the operation
Pregnant or breast-feeding women
Presence of other clinically significant concomitant disease states (ASA IV)
Uncontrolled diabetes mellitus
Contraindications to NSAIDs
Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus Erythematosus, SLE), gout, rheumatic arthritis
Known or suspected non-compliance, drug or alcohol abuse
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Participation in another study with investigational drug within the 30 days preceding and during the present study
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependent persons.

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Interventions

DRUGDexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)

Dexamethasone will be administered as an injectable solution (4mg/ml). Every ml of this solution contains 4 mg of dexamethasone sodium phosphate, corresponding to 3 mg of dexamethasone. Thus 3 ml of solution will be injected peri-articularly (arm-A)