Azsintjan
Bruges, 8000, Belgium
NCT Number: NCT03663426
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bruges, 8000, Belgium
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: measured at 24 hours after surgery.
opioid use postoperative at 24 hours
Time frame: measured at 24 hours after surgery.
Chronic reactive protein (CRP) change 24 h post-operative
Time frame: after surgery
surgeon scores the surgical conditions on an adapted five-point Leyden scale
Time frame: after surgery
surgeon scores the muscle damage on an adapted five-point Leyden scale
Time frame: until hospital discharge, maximum 7 days after surgery.
number days patient stay in the hospital before discharge
Time frame: 2 weeks postoperative
complications up to two weeks postoperative
AZ Sint-Jan AV
Other
Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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