The effect of different doses of dexamethasone in the duration of analgesia when used as an adjuvant in brachial plexus blocks

Phase 1

Conditions: postoperative pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-002815-32-BE

Lead Sponsor: AZ Groeninge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 75

Inclusion Criteria

All patients presenting for elective arthroscopic shoulder surgery (incl. decompression and cuff repairs), aged 18-85 years willing to sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Contraindications for brachial plexus blocks: coagulopathies, severe bronchopulmonary disease, intolerance to the study medication, pre-existing neuropathies, infection in the region of the interscalene groove.
•Weight <50kg
•Systemic glucocorticoid use
•Pregnancy
•Diabetes
•Chronic use of opioids
•History of addiction
•Oncologic history with chemotherapy (Taxol, Vincristine etc.)
•Known polyneuropathy
•Surgery or radiation therapy of the neck
•BMI >30
•Impossibility to understand and sign the informed consent
•Refusal of the patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: What is the effect of different doses of perineural dexamethasone<br>on postoperative analgesia after interscalene plexus block for shoulder<br>surgery.;Secondary Objective: What is the effect of different doses of dexamethasone on postoperative<br>painscores, analgesic use, patient satisfaction, duration and quality of<br>motor block and sleep disturbance.;Primary end point(s): Time to first analgesic request;Timepoint(s) of evaluation of this end point: 48 hours

Secondary Outcome Measures