NCT03663426

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

Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hip Arthropathy

Interventions

Type	Name	Description
PROCEDURE	study 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.
PROCEDURE	control	1. No corticoids pre-operative. 2. Opioid anesthesia 3. Opioids post-operative after NSAID and paracetamol.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2018-09-10
• Last updated: 2019-11-20

Locations

1 site across 1 country: Belgium