Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

NCT ID: NCT04507412

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2032-08-31

Brief 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

Detailed 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.

Conditions

Arthroplasty, Replacement, Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

arm A

• 9 mg of i.v. dexamethasone

Group Type: EXPERIMENTAL

dexamethasone

Intervention Type: DRUG

perioperatively 9 mg i.v subministration

arm B

• no steroid supplementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dexamethasone

perioperatively 9 mg i.v subministration

Intervention Type: DRUG

Other Intervention Names

Steroids

Eligibility 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

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christian Candrian

OTHER

Sponsor Role: lead

Responsible Party

Christian Candrian

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Candrian, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

EOC

Locations

Christian Candrian

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christian Candrian, Prof.Dr.med

Role: CONTACT

christian.candrian@eoc.ch

+41 (0) 91 811 61 23

Gyözö Lehoczky, Dr.med

Role: CONTACT

Gyoezoe.Lehoczky@eoc.ch

+41918116431

Facility Contacts

Christian Candrian, Prof.Dr.med

Role: primary

christian.candrian@eoc.ch

+41 (0) 91 811 61 23

Gianluigi Capone, Dr.

Role: backup

gianluigi.capone@eoc.ch

Other Identifiers

ORL-ORT- 020

Identifier Type: -

Identifier Source: org_study_id