Status:
COMPLETED
Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Orthopaedic Surgery of the Foot and Ankle
Lead Sponsor:
Zealand University Hospital
Conditions:
Anesthesia, Local
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators 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 u...
Detailed Description
This is a randomised, blinded, placebo-controlled, multicentre, parallel, 3-arm clinical trial assessing the effects of adjunct intravenous dexamethasone + dexmedetomidine 1mcg/kg versus intravenous d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04818749
Start Date
June 2 2021
End Date
May 17 2023
Last Update
June 12 2023
Active Locations (2)
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1
Department of Anaesthesiology
Køge, Zealand Region of Denmark, Denmark, 4600
2
Department of Anaesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400