Combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in patients undergoing orthopaedic surgery of the foot and ankle. A randomised, blinded, placebo-controlled, parallel clinical trial.

Zealand University Hospital, Department of Anaesthesiology0 个研究点目标入组 120 人开始时间: 2021年2月19日最近更新: 2021年5月17日

适应症

试验速览

暂无简介。

•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 or use of safe anti-conception.
•Ability to understand the trial protocol, risks, benefits, and provide signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Inability to read and understand Danish.
•Uncooperativeness.
•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.
•Dysregulated diabetes (as judged by investigators).
•Dysregulated anticoagulants (as judged by investigators).
•History of drug or alcohol abuse.
•Contraindications for paracetamol or opioids.
•Contraindications to general anaesthesia.
•Other concomitant conditions needing surgery.

发起方

Zealand University Hospital, Department of Anaesthesiology