Actively Recruiting
Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis on Post-operative Pain, Function, Nausea, Hospital Stay, and Risks
Led by Christian Candrian · Updated on 2026-03-05
74
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether giving intravenous steroid medication during surgery can improve outcomes for patients undergoing total shoulder arthroplasty, a type of shoulder replacement surgery. The study focuses on comparing steroid supplementation to routine pain control methods to see if it reduces post-operative pain and nausea, shortens hospital stays, improves shoulder movement and function, and increases patient satisfaction. It also looks at the safety of steroid use and its effects on inflammation and long-term recovery. Participants are randomly assigned to one of two groups: one receiving 9 mg of intravenous dexamethasone during surgery and the other receiving no steroid treatment. Both groups follow routine analgesia protocols otherwise. The study measures effects from the time of surgery through both short-term and long-term follow-ups, assessing pain, function, quality of life, drug use, inflammatory response, and complications. Steroid-related adverse effects and blood sugar levels are carefully monitored. During the study, participants will have their pain levels, shoulder function, satisfaction, and inflammation assessed regularly using validated clinical scores and questionnaires over periods ranging from days to several years. Hospital stay length, time to first movement and sleep, as well as the occurrence of frozen shoulder will be recorded. Safety monitoring includes tracking any adverse events related to treatment. Overall, participants may be involved for up to 10 years to evaluate both early and long-term outcomes.
CONDITIONS
Brief Title
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing unilateral primary total anatomical or reverse shoulder arthroplasty
- Body Mass Index (BMI) greater than 18.5 and less than 35
- Ability to provide informed consent and follow the study procedures
- Signed informed consent form
You will not qualify if you...
- Contraindications to steroids
- Revision or post-traumatic total shoulder arthroplasty
- Use of steroid or immunosuppressive therapy within 30 days before surgery
- Pregnant or breastfeeding women
- Presence of other serious medical conditions classified as ASA IV
- Uncontrolled diabetes mellitus
- Contraindications to non-steroidal anti-inflammatory drugs
- Chronic systemic diseases such as immunodeficiency, autoimmune diseases (e.g., systemic lupus erythematosus), gout, or rheumatoid arthritis
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days before or during this study
- Previous enrollment in this study
- Investigator or related persons enrolled in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay (approximately 1 to 3 days)
Participants undergo total shoulder arthroplasty surgery and receive perioperative intravenous dexamethasone or routine analgesia as assigned.
Daily visits during hospital stay for 3 days post-surgery
Duration - Up to 120 months after surgery
Participants are followed up to assess pain, shoulder function, patient satisfaction, and adverse events over short-, mid-, and long-term periods.
Visits at 2 and 6 weeks, and at 3, 6, 12, 24, 60, and 120 months post-surgery
Trial Site Locations
Total: 1 location
1
Christian Candrian
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
C
Christian Candrian, Prof.Dr.med
G
Gyözö Lehoczky, Dr.med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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