Hip ArthropathyNCT03663426
Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
A study testing study group in people with Hip Arthropathy, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- study group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthroplasty by anterior approach
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Hip Arthropathy
- Being tested
- study group, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study groupProcedure or surgery
- 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.
controlProcedure or surgery
- No corticoids pre-operative.
- Opioid anesthesia
- Opioids post-operative after NSAID and paracetamol.
| Study group | Role | What they receive |
|---|---|---|
| control group opioid anesthesia | Active comparator | standard anesthesia using opioids Receives: Procedure: control |
| study group opioid free anesthesia | Experimental | opioid free anesthesia and high dose glucocorticoids Receives: Procedure: study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured at 24 hours after surgery.
opioids postoperative
opioid use postoperative at 24 hours
Measured: measured at 24 hours after surgery.
CRP
Chronic reactive protein (CRP) change 24 h post-operative
Measured: measured at 24 hours after surgery.
Secondary outcomes (4)
surgical condition
surgeon scores the surgical conditions on an adapted five-point Leyden scale
Measured: after surgery
muscle damage
surgeon scores the muscle damage on an adapted five-point Leyden scale
Measured: after surgery
length of hospital stay
number days patient stay in the hospital before discharge
Measured: until hospital discharge, maximum 7 days after surgery.
complications
complications up to two weeks postoperative
Measured: 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Mar 2019
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Marco Lanckneus, MD, Study director, AZSint Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663426
- Sponsor's protocol ID
- RCT impact OFA on THP
- Status last verified
- Nov 2019
- First submitted
- 4 Sep 2018
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Study in Hip Arthroplasty by Direct Anterior Approach Using Opioid Free Anesthesia (OFA) Versus Standard Opioid Anesthesia.
- ClinicalTrials.gov ID
- NCT03663426
- Acronym / sponsor ID
- RCT impact OFA on THP
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group opioid anesthesia | Active comparator | Procedure: controlstandard anesthesia using opioids |
| study group opioid free anesthesia | Experimental | Procedure: study groupopioid free anesthesia and high dose glucocorticoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- arthroplasty by anterior approach
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study group1. 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. | Procedure or surgery | study group opioid free anesthesia |
| control1. No corticoids pre-operative. 2. Opioid anesthesia 3. Opioids post-operative after NSAID and paracetamol. | Procedure or surgery | control group opioid anesthesia |
Primary outcome
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.
opioids postoperative
Time frame: measured at 24 hours after surgery.
opioid use postoperative at 24 hours
CRP
Time frame: measured at 24 hours after surgery.
Chronic reactive protein (CRP) change 24 h post-operative
4 secondary outcomes
surgical condition
Time frame: after surgery
muscle damage
Time frame: after surgery
length of hospital stay
Time frame: until hospital discharge, maximum 7 days after surgery.
complications
Time frame: 2 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Hip Arthropathy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Safety and Effectiveness of the HIT Reverse HRS
Degenerative Joint Disease, Osteoarthritis, Hip
RecruitingObservational study
Evaluation of Arthroplasty Treatment
Surgery, Knee Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Lanckneus, MD study director
AZSint Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study group in people with Hip Arthropathy, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR15 (time frame: measured at 24 hours after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.