The effect of perioperative dexamethasone administration on postoperative pain in patients undergoing periacetabular osteotomy:A randomised double-blind, placebo-controlled trial - PAODEX

Viktoria Lindberg-Larsen0 个研究点目标入组 90 人开始时间: 2019年3月14日最近更新: 2024年3月18日

适应症

试验速览

暂无简介。

•1.Patients undergoing periacetabular osteotomy due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
•2.= 18 years
•3.Females if fertile*: Verified negative s-HCG, usage of safe contraceptives** or surgical sterilisation.
•4.Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
•*Postmenopausal is defined as >12months amenorrhoea.
•**Safe contraceptives accepted: intrauterine device or hormone contraceptives.
•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 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1.Patients who cannot speak or understand Danish
•2.Allergy or contraindications to trial medication
•3.Spinal anaesthesia
•4.Second intervention carried out simultaneously (e.g. femur osteotomy)
•5.Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
•6.Drug, medical abuse or weekly alcohol consumption beyond =7 (female) and =14 (men) units, respectively.
•7.Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
•8.Diabetes diagnosed prior to inclusion
•9.Immune suppression therapy (e.g. systemic glucocorticoids)
•10.Kidney impairment (eGFR < 50ml/min) or liver disease (=Child Pugh B)

发起方

Viktoria Lindberg-Larsen