Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.

Study Overview
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Brief Summary
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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.

Detailed Description
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study group means for Anesthesia: High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg). 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)

Official Title
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Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.

Conditions
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Hip Arthropathy

Intervention / Treatment
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* Procedure: study group
* Procedure: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: arthroplasty by anterior approach Exclusion Criteria: allergy or impossible to use any of the drugs included revision procedure major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group opioid anesthesia<br>standard anesthesia using opioids | Procedure: control<br>* No corticoids pre-operative. Opioid anesthesia Opioids post-operative after NSAID and paracetamol.<br>|
| Experimental: study group opioid free anesthesia<br>opioid free anesthesia and high dose glucocorticoids | Procedure: study group<br>* High dose corticoids pre-operative and 24h postoperative Opioid free general anesthesia Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR15 | quality of recovery (QoR15) measured by 15 questions evaluating condition of recovery) scale 0 to 15 with 0 being very bad while 15 being maximum recovery possible or equal to pre operative state. | measured at 24 hours after surgery. | 
| opioids postoperative | opioid use postoperative at 24 hours | measured at 24 hours after surgery. | 
| CRP | Chronic reactive protein (CRP) change 24 h post-operative | measured at 24 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical condition | surgeon scores the surgical conditions on an adapted five-point Leyden scale | after surgery | 
| muscle damage | surgeon scores the muscle damage on an adapted five-point Leyden scale | after surgery | 
| length of hospital stay | number days patient stay in the hospital before discharge | until hospital discharge, maximum 7 days after surgery. | 
| complications | complications up to two weeks postoperative | 2 weeks postoperative |