Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hip Arthropathy
- Sponsor
- AZ Sint-Jan AV
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- QoR15
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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)
Investigators
Jan Mulier
head of dep anesthesia & intensive care
AZ Sint-Jan AV
Eligibility Criteria
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
Outcomes
Primary Outcomes
QoR15
Time Frame: measured at 24 hours after surgery.
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.
opioids postoperative
Time Frame: measured at 24 hours after surgery.
opioid use postoperative at 24 hours
CRP
Time Frame: measured at 24 hours after surgery.
Chronic reactive protein (CRP) change 24 h post-operative
Secondary Outcomes
- length of hospital stay(until hospital discharge, maximum 7 days after surgery.)
- complications(2 weeks postoperative)
- surgical condition(after surgery)
- muscle damage(after surgery)