Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age58-85
SponsorChristian Candrian

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • dexamethasone

    Drug

    perioperatively 9 mg i.v subministration

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: arm AExperimental treatment 1 intervention
Group B: arm BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

mean post-operative daily pain at rest

0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful

Time frame
first 3 days after surgery

Secondary outcomes

1

Post-operative shoulder pain

0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful

Time frame
first 3 months after surgery
2

Post-operative shoulder pain

0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
3

Post-operative global shoulder function score

0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional

Time frame
daily during the first 3 months
4

Post-operative global shoulder function score

0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery

Other outcomes

1

Rate of serious adverse events related to steroid supplementation

Rate of serious adverse events related to steroid supplementation

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
2

Rate of prosthetic joint infections

Rate of prosthetic joint infections

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
3

Rate of wound infections

Rate of wound infections

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
4

Rate of wound healing problems

Rate of wound healing problems

Time frame
2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Candrian

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution