Hip Arthropathy
Conditions
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)
Interventions
PROCEDUREstudy group
1. High dose corticoids pre-operative and 24h postoperative 2. Opioid free general anesthesia 3. Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.
PROCEDUREcontrol
1. No corticoids pre-operative. 2. Opioid anesthesia 3. Opioids post-operative after NSAID and paracetamol.
Sponsors
AZ Sint-Jan AV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR15 | 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 | measured at 24 hours after surgery. | opioid use postoperative at 24 hours |
| CRP | measured at 24 hours after surgery. | Chronic reactive protein (CRP) change 24 h post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical condition | after surgery | surgeon scores the surgical conditions on an adapted five-point Leyden scale |
| complications | 2 weeks postoperative | complications up to two weeks postoperative |
| muscle damage | after surgery | surgeon scores the muscle damage on an adapted five-point Leyden scale |
| length of hospital stay | until hospital discharge, maximum 7 days after surgery. | number days patient stay in the hospital before discharge |
Countries
Belgium
Outcome results
None listed