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.

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 Overview

• Status: Completed
• Conditions: Hip Arthropathy
• Intervention / Treatment: Procedure: control; Procedure: study group

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group opioid anesthesia; standard anesthesia using opioids	Procedure: control; No corticoids pre-operative.; Opioid anesthesia; Opioids post-operative after NSAID and paracetamol.
Experimental: study group opioid free anesthesia; opioid free anesthesia and high dose glucocorticoids	Procedure: study group; High dose corticoids pre-operative and 24h postoperative; Opioid free general anesthesia; Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Study Director: Marco Lanckneus, MD, AZSint Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: RCT impact OFA on THP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No