Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.

Not Applicable

Completed

• Conditions: Hip Arthropathy
• Interventions: Procedure: control; Procedure: study group

• Registration Number: NCT03663426
• Lead Sponsor: AZ Sint-Jan AV

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)

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Study Start: 2019-03-01
• Primary Completion: 2019-10-01
• Status Verified: 2019-11
• Study Completion: 2019-11-01
• Last Update Submitted: 2019-11-17
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group opioid anesthesia	control	standard anesthesia using opioids
study group opioid free anesthesia	study group	opioid free anesthesia and high dose glucocorticoids

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
length of hospital stay	until hospital discharge, maximum 7 days after surgery.	number days patient stay in the hospital before discharge
complications	2 weeks postoperative	complications up to two weeks postoperative
surgical condition	after surgery	surgeon scores the surgical conditions on an adapted five-point Leyden scale
muscle damage	after surgery	surgeon scores the muscle damage on an adapted five-point Leyden scale

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium