Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty

Phase 4RecruitingNCT04507412

Christian Candrian74 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Arthroplasty, Replacement, Shoulder

Interventions

dexamethasoneDRUG

perioperatively 9 mg i.v subministration

Eligibility

Sex: ALLMin age: 58 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Christian Candrian

Lugano, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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

The clinician assessed Constant score

The Constant Score questionnaire consists of 8 questions (giving a score of 0 -100, with 100 being the best score) evaluating pain, activity level and range of motion

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

The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)

The ASES Score is a patient reported outcome measure (PROM), a validated score evaluating pain and function for daily living and leisure activity. A maximum of 100 points means maximum (normal) functionality and no pain. MCID is 13.6 ± 2.3 points after total shoulder prosthesis

Central 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

Data from ClinicalTrials.gov

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