Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Ner⦠(NCT04818749) | Clinical Trial Compass
CompletedPhase 4
Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Orthopaedic Surgery of the Foot and Ankle
Denmark120 participantsStarted 2021-06-02
Plain-language 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 undergoing surgery of their foot or ankle.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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