Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Recruiting
Phase 4Interventional Study
Arthroplasty, Replacement, Shoulder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
58 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
Christian Candrian · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Status
Eligibility 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 …
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
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