Using intravenous dexamethasone to improve outcomes after shoulder surgery
Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications
PHASE4 · Ente Ospedaliero Cantonale, Bellinzona · NCT04507412
This study is testing if giving intravenous dexamethasone during shoulder surgery can help patients feel less pain, recover better, and be happier with their results compared to standard pain relief methods.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 58 Years to 85 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona (other) |
| Locations | 1 site (Lugano) |
| Trial ID | NCT04507412 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravenous dexamethasone supplementation during total shoulder arthroplasty (TSA) surgeries compared to standard analgesia protocols. It aims to assess various outcomes including post-operative pain, nausea, shoulder function, patient satisfaction, and length of hospital stay. The study will monitor both short-term and long-term clinical outcomes, as well as any adverse events related to steroid use. Patient-reported and clinician-assessed measures will be utilized to gauge the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing unilateral primary total shoulder arthroplasty with a BMI between 18.5 and 35.
Not a fit: Patients with contraindications to steroids, those undergoing revision surgeries, or individuals with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and improve recovery times for patients undergoing shoulder surgery.
How similar studies have performed: Previous studies have shown promising results with steroid supplementation in surgical settings, suggesting potential benefits in pain management and recovery.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Lugano
- Christian Candrian — Lugano, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Christian Candrian, Prof.Dr.med — EOC
- Study coordinator: Christian Candrian, Prof.Dr.med
- Email: christian.candrian@eoc.ch
- Phone: +41 (0) 91 811 61 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthroplasty, Replacement, Shoulder, Total Shoulder Arthroplasty, steroid