Clinical trial NCT04507412: Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
Official title: Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Shoulder
Keywords: Total Shoulder Arthroplasty
steroid
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 74
Sex: ALL
Minimum age (years): 58
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mean post-operative daily pain at rest
timeFrame: first 3 days after surgery
Secondary outcomes:
measure: Post-operative shoulder pain
timeFrame: first 3 months after surgery
measure: Post-operative shoulder pain
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Post-operative global shoulder function score
timeFrame: daily during the first 3 months
measure: Post-operative global shoulder function score
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: The clinician assessed Constant score
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: The Subjective Shoulder Value (SSV)
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: European Quality of Life-5 Dimensions-3 Level
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: PainDETECT
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Patient satisfaction
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Post-operative nausea
timeFrame: first 3 days post-operative days during hospitalisation
measure: Post-operative opioids and analgesic drugs consumption
timeFrame: first 3 days post-operative days during hospitalisation
measure: Postoperative inflammatory response
timeFrame: preoperatively and first 3 days post-operative days during hospitalisation
measure: Time from surgery to first mobilization
timeFrame: During Hospitalization, approximately 1 days
measure: Rate of frozen shoulders
timeFrame: 1 week post-operative during hospitalisation
Other outcomes:
measure: Rate of serious adverse events related to steroid supplementation
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Rate of prosthetic joint infections
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Rate of wound infections
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
measure: Rate of wound healing problems
timeFrame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
Locations:
city: Lugano
country: Switzerland
facility: Christian Candrian
Study officials:
affiliation: EOC
name: Christian Candrian, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: