Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group opioid anesthesia | Active Comparator | standard anesthesia using opioids |
|
| study group opioid free anesthesia | Experimental | opioid free anesthesia and high dose glucocorticoids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| study group | Procedure |
|
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Lanckneus, MD | AZSint Jan AV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azsintjan | Bruges | 8000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control | Procedure |
|
|
| 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 |