Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial

Repeat Dose

The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population. As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA. The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.

2021-11-01

2024-03-22

2024-07-01

Active (not recruiting)

Early phase I

110

Inclusion Criteria: * Age ≥ 40 years. * 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. * PCS \>20. * Moderate to severe postoperative pain (VAS \>30) in a 5-meter walk test 22-26 hours after end of surgery. 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. * Peripheral nerve block per- or postoperatively. * Pregnancy: No women with suspected or proven pregnancy are eligible for inclusion. The following will be considered as safe contraception: intrauterine device or hormonal contraception. For women aged between 40-50 years, a urine HCG test for pregnancy will be performed.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blind randomization will be carried out, 5:5 block-randomization, half of which will be allocated to the CG and the other half to RDG.\n\nGroup 1: Postoperative placebo tablet on day 1 after surgery.\n\nGroup 2: Postoperative dexamethasone 24 mg tablet on day 1 after surgery.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Blinding The patient, all personnel attending in treatment and care of the patient, the investigators and the sponsor will all be blinded to the study-drug allocation, until all data processing is finished.\n\nThe randomization-sequence will be stored in a sealed envelope at the Pharmacy at Lillebaelt Hospital who carried out the packaging-process. The randomization personnel have no contact to the patient.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

2024-05-09