Status:
COMPLETED
Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand
Lead Sponsor:
Zealand University Hospital
Conditions:
Anesthesia, Local
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators will assess the beneficial and harmful effects of oral dexamethasone (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a latera...
Detailed Description
This is a randomised, blinded, placebo-controlled, multicentre, parallel, 3-arm clinical trial assessing the effects of adjunct oral dexamethasone (12mg or 24mg) versus placebo on time to first pain (...
Eligibility Criteria
Inclusion
- Scheduled for unilateral osseous surgery of the hand or forearm.
- Anaesthesia with an infraclavicular brachial plexus block
- Age of 18 or above
- American Society of Anaesthesiologists Physical Status Score of 1 to 3
- Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
- For fertile women, negative urine humane choriongonadotropine test and use of safe anti-conception
- Ability to understand the trial protocol, risks and benefits, and provide signed informed consent
Exclusion
- Inability to read and understand Danish
- Uncooperativeness (as judged by investigators)
- Participation in another trial involving medication
- Allergy to study medication
- Daily use of opioids above 30 mg/day morphine (or equivalents)
- Daily use of corticosteroids of more than 5 mg prednisolone equivalents within the past one month
- Neurological or musculoskeletal disease making block performance impossible (as judged by investigators)
- Dysregulated diabetes (as judged by investigators)
- Dysregulated anti-coagulants (as judged by investigators)
- History of drug or alcohol abuse
- Glaucoma
- Contraindications for paracetamol or opioids
- Other concomitant conditions needing surgery
- Other concomitant traumatic injuries
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04853446
Start Date
June 28 2021
End Date
May 4 2023
Last Update
May 25 2023
Active Locations (3)
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1
Department of Anaesthesiology
Køge, Zealand Region of Denmark, Denmark, 4600
2
Department of Anaesthesiology
Slagelse, Zealand Region of Denmark, Denmark, 4200
3
Department of Anaesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400