Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
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|ClinicalTrials.gov Identifier: NCT03663426|
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : November 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hip Arthropathy||Procedure: study group Procedure: control||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||November 1, 2019|
Active Comparator: control group opioid anesthesia
standard anesthesia using opioids
Experimental: study group opioid free anesthesia
opioid free anesthesia and high dose glucocorticoids
Procedure: study group
- 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
- surgical condition [ Time Frame: after surgery ]surgeon scores the surgical conditions on an adapted five-point Leyden scale
- muscle damage [ Time Frame: after surgery ]surgeon scores the muscle damage on an adapted five-point Leyden scale
- length of hospital stay [ Time Frame: until hospital discharge, maximum 7 days after surgery. ]number days patient stay in the hospital before discharge
- complications [ Time Frame: 2 weeks postoperative ]complications up to two weeks postoperative
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663426
|Brugge, Belgium, 8000|
|Study Director:||Marco Lanckneus, MD||AZSint Jan AV|