Status:
RECRUITING
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Lead Sponsor:
Christian Candrian
Conditions:
Arthroplasty, Replacement, Shoulder
Eligibility:
All Genders
58-85 years
Phase:
PHASE4
Brief 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 hosp...
Detailed Description
The purpose of this study is to detect the efficacy of intravenous perioperative steroid supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and long-term clinical o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2032
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04507412
Start Date
September 9 2020
End Date
August 31 2032
Last Update
September 19 2024
Active Locations (1)
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1
Christian Candrian
Lugano, Switzerland, 6900