Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

NCT04507412 | Recruiting Phase 4

• 1 other identifier: ORL-ORT- 020
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Arthroplasty, Replacement, Shoulder

Keywords

Total Shoulder Arthroplasty; steroid

Outcome Measures

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

  first 3 days after surgery

Secondary Outcomes (15)

• Post-operative shoulder pain

  first 3 months after surgery

• Post-operative shoulder pain

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

• Post-operative global shoulder function score

  daily during the first 3 months

• Post-operative global shoulder function score

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

• The clinician assessed Constant score

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

Other Outcomes (4)

• Rate of serious adverse events related to steroid supplementation

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

• Rate of prosthetic joint infections

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

• Rate of wound infections

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

Study Arms (2)

arm A

EXPERIMENTAL

• 9 mg of i.v. dexamethasone

Drug: dexamethasone

arm B

NO INTERVENTION

• no steroid supplementation

Interventions

dexamethasone DRUG

perioperatively 9 mg i.v subministration

Also known as: Steroids

arm A

Eligibility Criteria

• Age: 58 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Candrian: lead

Study Sites (1)

Christian Candrian

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Steroids

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Christian Candrian, Prof.Dr.med

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Candrian, Prof.Dr.med

CONTACT

+41 (0) 91 811 61 23; christian.candrian@eoc.ch

Gyözö Lehoczky, Dr.med

CONTACT

+41918116431; Gyoezoe.Lehoczky@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The present study will be double blinded: both participants and assessors will be blinded to the assigned treatment. Surgeons will be also blinded, only anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a 2-arm randomized controlled trial comparing i.v. dexamethasone supplementation (arm-A) and no steroid supplementation (arm-B) for total shoulder arthroplasty

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: September 9, 2020
• Primary Completion (Estimated): July 31, 2032
• Study Completion (Estimated): August 31, 2032
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)