RecruitingPhase 4NCT04507412

Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications

Sponsor

Christian Candrian

Enrollment

74 participants

Start Date

Sep 9, 2020

Study Type

INTERVENTIONAL

Conditions

Arthroplasty, Replacement, Shoulder

Summary

The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction

Eligibility

Min Age: 58 YearsMax Age: 85 Years

Inclusion Criteria4

Patients undergoing unilateral primary total anatomical or reverse shoulder arthroplasty (Total Shoulder Arthroplasty)
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 and post-traumatic TSA
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 Non-steroidal anti-inflammatory drugs
Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus Erythematosus), 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