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OpenTrials
Completed

NCT Number: NCT03663426

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azsintjan

Bruges, 8000, Belgium

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

study group

Procedure
  • 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.

Control

Procedure
  • No corticoids pre-operative.
  • Opioid anesthesia
  • Opioids post-operative after NSAID and paracetamol.

Primary outcomes

  1. 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.

  2. opioids postoperative

    Time frame: measured at 24 hours after surgery.

    opioid use postoperative at 24 hours

  3. CRP

    Time frame: measured at 24 hours after surgery.

    Chronic reactive protein (CRP) change 24 h post-operative

Secondary outcomes

  1. surgical condition

    Time frame: after surgery

    surgeon scores the surgical conditions on an adapted five-point Leyden scale

  2. muscle damage

    Time frame: after surgery

    surgeon scores the muscle damage on an adapted five-point Leyden scale

  3. length of hospital stay

    Time frame: until hospital discharge, maximum 7 days after surgery.

    number days patient stay in the hospital before discharge

  4. complications

    Time frame: 2 weeks postoperative

    complications up to two weeks postoperative

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Nov 20, 2019

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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