Overview
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Status:
Recruiting
Recruiting
Trial end date:
2030-08-31
2030-08-31
Target enrollment:
0
0
Participant gender:
All
All
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 satisfactionPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Christian CandrianTreatments:
Dexamethasone
Criteria
Inclusion Criteria:- 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 Criteria:
- 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