Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

We will assess the beneficial and harmful effects of oral dexamethason (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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