Anterior Cruciate Ligament ReconstructionPhase 4CLICANCT02257164
Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial
A Phase 4 study testing Femoral nerve block, obturator nerve block and intraarticular injection in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Femoral nerve block, obturator nerve block and intraarticular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 4
- 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
- Physical Status score = 1 or Physical Status score = 2
- Major Patient
- indication of anterior cruciate ligament reconstruction
- informed consent for participation in the study
Who cannot join
- Contraindication to general analgesia
- Contraindication to peripheral nerve block
- Allergy to analgesic treatment
- Porphyria,
- Neurologic deficit
- Contraindication antiinflammatory drugs
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- Simultaneous reconstruction of another ligament or complex gesture intended
- Patient treated with an anti-arrhythmic drug class III
- Patient with severe hepatic impairment
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.
In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.
Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee
- Being tested
- Femoral nerve block, obturator nerve block, intraarticular injection
- Keywords
- anterior cruciate ligament reconstruction, femoral nerve block, articular injection and obturator nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
2 mg/ml
obturator nerve blockProcedure or surgery
intraarticular injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| femoral nerve block | Active comparator | 20 ml injection of 2 mg/ml ropivacaine in femoral nerve Receives: Procedure: Femoral nerve block |
| obturator nerve block and intraarticular injection | Experimental | 10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate Receives: Procedure: obturator nerve block; Procedure: intraarticular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with success
success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5
Measured: 4 postoperative hours
Secondary outcomes (3)
Pain for all patients
pain measured by EVA
Measured: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
analgesic consumption for all patients
analgesic consumption of tramadol and morphine (use, number)
Measured: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
analgesic adverse events for all patients
Frequency of nausea and vomiting
Measured: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie PASSOT, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257164
- Sponsor's protocol ID
- 1408021
- Other IDs
- 2014-002062-77, 2014
- Acronym
- CLICA
- Status last verified
- Jan 2015
- First submitted
- 30 Sep 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial
- ClinicalTrials.gov ID
- NCT02257164
- Acronym / sponsor ID
- CLICA / 1408021
- Keywords
- anterior cruciate ligament reconstruction, femoral nerve block, articular injection and obturator nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Oct 2014 (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.
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.
In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.
Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral nerve block | Active comparator | Procedure: Femoral nerve block20 ml injection of 2 mg/ml ropivacaine in femoral nerve |
| obturator nerve block and intraarticular injection | Experimental | Procedure: obturator nerve block, Procedure: intraarticular injection10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical Status score = 1 or Physical Status score = 2
- Major Patient
- indication of anterior cruciate ligament reconstruction
- informed consent for participation in the study
Key exclusion criteria (10 listed)
- Contraindication to general analgesia
- Contraindication to peripheral nerve block
- Allergy to analgesic treatment
- Porphyria,
- Neurologic deficit
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 |
|---|---|---|
| Femoral nerve block2 mg/ml | Procedure or surgery | femoral nerve block |
| obturator nerve block | Procedure or surgery | obturator nerve block and intraarticular injection |
| intraarticular injection | Procedure or surgery | obturator nerve block and intraarticular injection |
Primary outcome
number of patients with success
Time frame: 4 postoperative hours
success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5
3 secondary outcomes
Pain for all patients
Time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
analgesic consumption for all patients
Time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
analgesic adverse events for all patients
Time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
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 1 Jul 2015.
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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.
Sylvie PASSOT, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Femoral nerve block, obturator nerve block and intraarticular injection in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 10 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 1 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
number of patients with success (time frame: 4 postoperative hours). 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 1 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.