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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663426
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Mulier, 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.


Condition or disease Intervention/treatment Phase
Hip Arthropathy Procedure: study group Procedure: control Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: control group opioid anesthesia
standard anesthesia using opioids
Procedure: control
  1. No corticoids pre-operative.
  2. Opioid anesthesia
  3. Opioids post-operative after NSAID and paracetamol.

Experimental: study group opioid free anesthesia
opioid free anesthesia and high dose glucocorticoids
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Belgium
Azsintjan
Brugge, Belgium, 8000
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Study Director: Marco Lanckneus, MD AZSint Jan AV
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Responsible Party: Jan Mulier, head of dep anesthesia & intensive care, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03663426    
Other Study ID Numbers: RCT impact OFA on THP
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases