Overview

Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

Status:
Recruiting
Trial end date:
2030-08-31
Target enrollment:
0
Participant gender:
All
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 hospital stay, shoulder range of motion, function and patient satisfaction
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Christian Candrian
Treatments:
Dexamethasone
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