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.
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedNovember 20, 2019
November 1, 2019
7 months
September 4, 2018
November 17, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
surgical condition
after surgery
muscle damage
after surgery
length of hospital stay
until hospital discharge, maximum 7 days after surgery.
complications
2 weeks postoperative
Study Arms (2)
control group opioid anesthesia
ACTIVE COMPARATORstandard anesthesia using opioids
study group opioid free anesthesia
EXPERIMENTALopioid free anesthesia and high dose glucocorticoids
Interventions
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.
1. No corticoids pre-operative. 2. Opioid anesthesia 3. Opioids post-operative after NSAID and paracetamol.
Eligibility Criteria
You may qualify if:
- arthroplasty by anterior approach
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
Study Sites (1)
Azsintjan
Bruges, 8000, Belgium
Study Officials
- STUDY DIRECTOR
Marco Lanckneus, MD
AZSint Jan AV
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of dep anesthesia & intensive care
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 10, 2018
Study Start
March 1, 2019
Primary Completion
October 1, 2019
Study Completion
November 1, 2019
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share