Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
Primary Purpose
Hip Arthropathy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
study group
control
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthropathy
Eligibility 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
Sites / Locations
- Azsintjan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group opioid anesthesia
study group opioid free anesthesia
Arm Description
standard anesthesia using opioids
opioid free anesthesia and high dose glucocorticoids
Outcomes
Primary Outcome Measures
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.
opioids postoperative
opioid use postoperative at 24 hours
CRP
Chronic reactive protein (CRP) change 24 h post-operative
Secondary Outcome Measures
surgical condition
surgeon scores the surgical conditions on an adapted five-point Leyden scale
muscle damage
surgeon scores the muscle damage on an adapted five-point Leyden scale
length of hospital stay
number days patient stay in the hospital before discharge
complications
complications up to two weeks postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03663426
Brief Title
Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
Official Title
Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group opioid anesthesia
Arm Type
Active Comparator
Arm Description
standard anesthesia using opioids
Arm Title
study group opioid free anesthesia
Arm Type
Experimental
Arm Description
opioid free anesthesia and high dose glucocorticoids
Intervention Type
Procedure
Intervention Name(s)
study group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
No corticoids pre-operative.
Opioid anesthesia
Opioids post-operative after NSAID and paracetamol.
Primary Outcome Measure Information:
Title
QoR15
Description
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.
Time Frame
measured at 24 hours after surgery.
Title
opioids postoperative
Description
opioid use postoperative at 24 hours
Time Frame
measured at 24 hours after surgery.
Title
CRP
Description
Chronic reactive protein (CRP) change 24 h post-operative
Time Frame
measured at 24 hours after surgery.
Secondary Outcome Measure Information:
Title
surgical condition
Description
surgeon scores the surgical conditions on an adapted five-point Leyden scale
Time Frame
after surgery
Title
muscle damage
Description
surgeon scores the muscle damage on an adapted five-point Leyden scale
Time Frame
after surgery
Title
length of hospital stay
Description
number days patient stay in the hospital before discharge
Time Frame
until hospital discharge, maximum 7 days after surgery.
Title
complications
Description
complications up to two weeks postoperative
Time Frame
2 weeks postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Lanckneus, MD
Organizational Affiliation
AZSint Jan AV
Official's Role
Study Director
Facility Information:
Facility Name
Azsintjan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
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