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Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol. control means no high steroid dose, opioids for anesthesia; paracetamol, NSAIDs and opioids as analgesia. study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, NSAIDs and if needed opioids as escape.
study group means for Anesthesia: 1. High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative 2. OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg). 3. Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization. all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) \< 3 by continuous infusion and monitoring of NMB. Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation \< 20% to reduce wound edema. The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Azsintjan
Bruges, Belgium
Start Date
March 1, 2019
Primary Completion Date
October 1, 2019
Completion Date
November 1, 2019
Last Updated
November 20, 2019
42
ACTUAL participants
study group
PROCEDURE
control
PROCEDURE
Lead Sponsor
AZ Sint-Jan AV
NCT05956236
NCT06233604
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06308003