Repeat dose steroid to prevent pain relapse after Total Knee Arthroplasty in patients with high pain response - A randomized blinded placebo-controlled trial

Vejle Sygehus, Ortopædkirurgisk afdeling, Forskningsenheden (COFU)0 个研究点目标入组 100 人开始时间: 2021年3月31日最近更新: 2024年4月29日

试验速览

暂无简介。

•Inclusion criteria
•Primary unilateral TKA
•Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
•Signed written informed consent form
•Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test in the morning the first day after surgery between 8 am and 12 am (16-26 hours postoperatively).
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Exclusion criteria
•Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
•Insulin-dependent diabetes.
•Pregnancy or breastfeeding.*
•Allergies concerning the study-drug.
•Mental disability that could impair a patient’s decision-making capability of giving informed consent and not enabling valid data collection.
•Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
•Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
•*Pregnancy: No women with suspected or proven pregnancy is eligible for inclusion.

发起方

Vejle Sygehus, Ortopædkirurgisk afdeling, Forskningsenheden (COFU)