Overview

Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Orthopaedic Surgery of the Foot and Ankle

Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
Summary
We will investigate the beneficial and harmful effects of combining dexamethasone (12 mg) and dexmedetomidine (1mcg/kg) as adjuncts to popliteal and saphenous nerve blocks in patients undergoing surgery of their foot or ankle.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zealand University Hospital
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Criteria
Inclusion Criteria:

- Scheduled for unilateral osseous surgery of the ankle or foot

- General anaesthesia with both a popliteal and a saphenous nerve block for
postoperative analgesia

- 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, 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 anticoagulants (as judged by investigators)

- History of drug or alcohol abuse

- Glaucoma

- Contraindications for paracetamol or opioids

- Contraindications to general anaesthesia

- Other concomitant conditions needing surgery

- Other concomitant traumatic injuries