About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
dexamethasone
Drugperioperatively 9 mg i.v subministration
Treatment groups
Trial outcomes
Primary outcomes
mean post-operative daily pain at rest
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Secondary outcomes
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Post-operative shoulder pain
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
Post-operative global shoulder function score
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
Post-operative global shoulder function score
0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
Other outcomes
Rate of serious adverse events related to steroid supplementation
Rate of serious adverse events related to steroid supplementation
Rate of prosthetic joint infections
Rate of prosthetic joint infections
Rate of wound infections
Rate of wound infections
Rate of wound healing problems
Rate of wound healing problems
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Christian Candrian
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution