Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Recruiting · NCT04507412 · Interventional (participants receive a specific treatment) · Lead sponsor: Christian Candrian
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
58 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Christian Candrian - Lugano, Switzerland