Actively Recruiting

Phase 4
Age: 58Years - 85Years
All Genders
ID04507412

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

Age: 58Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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