Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

Christian Candrian

Status and phase

Enrolling

Phase 4

Conditions

Arthroplasty, Replacement, Shoulder

Treatments

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04507412

ORL-ORT- 020

Details and patient eligibility

About

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

Full description

The purpose of this study is to detect the efficacy of intravenous perioperative steroid supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and long-term clinical outcomes and to demonstrate its advantages over the routine anaesthesia protocol. The comparison will be evaluated in terms of post- operative pain and function, opioids and analgesic drugs consumption, patient satisfaction, patient reported outcome measures (validated clinical scores), clinician-assessed clinical scores, systemic inflammatory response, length of hospital stay and long-term outcomes. Moreover, to confirm the safety of steroid supplementation all treatment related adverse events- and reactions are going to be recorded and reported, as well as post-operative glycaemia will be monitored.

The primary objective of the study is to show the efficacy on post-operative pain of intravenous perioperative dexamethasone supplementation for TSA.

The secondary objectives of the study are to show superiority by comparison of the intravenous peri- operative dexamethasone supplementation group to the routine analgesia protocol (no steroid supplementation group), in terms of post-operative pain and function, patient satisfaction, shoulder active- and passive range of motion, quantification with validated clinician- and patient reported outcome measures as the Constant, ASES and SSV Scores for function and EQ-5D-3L Score for health-related quality of life, opioids and analgesic drugs consumption, systemic inflammatory response, time until first mobilization and until the patient first slept through at night, the length of hospital stay and presence or absence of a frozen shoulder at the postoperative follow-up, as well as adverse events and reactions, in order to document the advantage over the absence of steroid supplementation in the short-, mid- term- and long-term follow up.

Enrollment

74 estimated patients

Sex

All

Ages

58 to 85 years old

Volunteers

No Healthy Volunteers

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