Total Hip ReplacementPhase 3ALRIALNCT02720471
Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement
A Phase 3 study testing Locoregional anesthesia and peroperative infiltration of local anesthetics in people with Total Hip Replacement, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Locoregional anesthesia and peroperative infiltration of local anesthetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2015to Mar 2017
- Phase
- Phase 3
- 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
- Men or women > or = 18 years old
- Surgery for total hip replacement (THR)
- Unilateral THR
- First THR
- THR planned because of a degenerative disease or after a traumatism
- Whatever the technique of anesthesia (general anesthesia or intra thecal anesthesia)
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- Whatever the surgery technique/surgical approach
- Patient with a social security protection
- Patient not under juridic protection
- Agreement for the study signed by the patient himself or, if he is not able to sign, by his trusted person.
Who cannot join
- Patient Refusal
- Second hip replacement
- Pregnancy or breastfeeding
- Porphyria
- Risks to have methemoglobinemia (G6PD deficit, hemoglobin disease)
- BMI> 40 kg/m2 ou < 18 kg/m2
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- Allergy to any of the drugs used in this study
- Contraindication to any of the technic used in this study
- Factors wich could influence the perception of pain (depression, dementia, psychiatric illness, neurologic disease with sensitivity troubles)
- Usual consumption of opioids
- Systemic or articular infection
- Participation to an other research that could interfere in this study
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Département d'anesthésie réanimation
Lyon, 69437
About this study
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier.
The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours.
The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.
- Conditions
- Total Hip Replacement
- Being tested
- Locoregional anesthesia, peroperative infiltration of local anesthetics
- Keywords
- local analgesia, total hip replacement, local infiltrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locoregional anesthesiaDrug
classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh
peroperative infiltration of local anestheticsDrug
peroperative infiltration of local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Locoregional anesthesia | Active comparator | Classical locoregional analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh will be performed in patients of this arm Receives: Drug: Locoregional anesthesia |
| Peroperative infiltration | Experimental | Peroperative infiltration of local anesthetics (IAL) will be performed in patients of this arm Receives: Drug: peroperative infiltration of local anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of morphine consumed
Morphine consumption will be measured within the 72 hours following surgery
Measured: 72 hours after surgery
Secondary outcomes (4)
Pain at rest
Visual analogic pain scale (EVA) will be used to evaluate patient's pain at rest within the 72 hours following surgery
Measured: 72 hours after surgery
Pain while moving
Visual analogic pain scale (EVA) will be used to evaluate patient's pain while moving within the 72 hours following surgery
Measured: 72 hours after surgery
Time between intervention and first support by the upright posture in bipedal station.
Period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal station.
Measured: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Time between intervention and resumption of the walk
Measured: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start14 Sep 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720471
- Sponsor's protocol ID
- 69HCL15_0189
- Acronym
- ALRIAL
- Status last verified
- Aug 2017
- First submitted
- 15 Dec 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02720471
- Acronym / sponsor ID
- ALRIAL / 69HCL15_0189
- Conditions
- Total Hip Replacement
- Keywords
- local analgesia, total hip replacement, local infiltrations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Mar 2016 (estimated)
- 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.
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier.
The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours.
The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locoregional anesthesia | Active comparator | Drug: Locoregional anesthesiaClassical locoregional analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh will be performed in patients of this arm |
| Peroperative infiltration | Experimental | Drug: peroperative infiltration of local anestheticsPeroperative infiltration of local anesthetics (IAL) will be performed in patients of this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women > or = 18 years old
- Surgery for total hip replacement (THR)
- Unilateral THR
- First THR
- THR planned because of a degenerative disease or after a traumatism
Key exclusion criteria (12 listed)
- Patient Refusal
- Second hip replacement
- Pregnancy or breastfeeding
- Porphyria
- Risks to have methemoglobinemia (G6PD deficit, hemoglobin disease)
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 |
|---|---|---|
| Locoregional anesthesiaclassical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh | Drug | Locoregional anesthesia |
| peroperative infiltration of local anestheticsperoperative infiltration of local anesthetics | Drug | Peroperative infiltration |
Primary outcome
Quantity of morphine consumed
Time frame: 72 hours after surgery
Morphine consumption will be measured within the 72 hours following surgery
4 secondary outcomes
Pain at rest
Time frame: 72 hours after surgery
Pain while moving
Time frame: 72 hours after surgery
Time between intervention and first support by the upright posture in bipedal station.
Time frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
Time between intervention and resumption of the walk
Time frame: From date of surgery until the date of first documented resumption of walk, assessed up to 20 days after surgery
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 9 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Locoregional anesthesia and peroperative infiltration of local anesthetics in people with Total Hip Replacement, run by Hospices Civils de Lyon at 1 site in France.
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 10 inclusion and 12 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 9 Aug 2017. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantity of morphine consumed (time frame: 72 hours after surgery). 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 9 Aug 2017.