Femoral NeuropathyNCT01321138
Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
A study testing Femoral nerve block and PCA morphine in people with Femoral Neuropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block may be as high as 24% at 6 postoperative weeks when evaluated prospectively and systematically through a clinical neurological and an electroneuromyography (ENMG). Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Neuropathy
- What is being tested?
- Femoral nerve block and PCA morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2011to Nov 2015
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients planned for anterior cruciate ligament reconstruction
- ASA 1 and 2
- age 16 years and more
Who cannot join
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
- cancer with chemotherapy
- chronic pain state
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)
Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block may be as high as 24% at 6 postoperative weeks when evaluated prospectively and systematically through a clinical neurological and an electroneuromyography (ENMG). It is still unclear whether this neuropathy is the result of the surgery, especially the Tourniquet, or the block nerve. The goal of this study is to define the etiology of this postoperative neuropathy.
Read the detailed description
Anterior cruciate ligament reconstruction is associated with moderate to severe postoperative pain. Among different analgesic strategies, continuous femoral nerve block is reported as an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients, particularly on athletes who need immediate rehabilitation and who will put their knee to greater use during the postoperative period. This study is designed to compare the incidence of femoral neuropathy in two groups of patients: one with a femoral nerve block, and one with a PCA of morphine (self-iv administration of morphine). All patients will have a clinical neurological exam with a preoperative ENMG in order to rule out a pre-existing neuropathy. Another clinical neurological exam with ENMG will be performed between 4 and 6 weeks and, if pathological, repeated at 6 months, 9 months and 12 months. The operation will be done under general anesthesia for all patients.
- Conditions
- Femoral Neuropathy
- Being tested
- Femoral nerve block, PCA morphine
- Keywords
- Electrophysiological study, Nerve block, Analgesia, Patient-Controlled, Anterior cruciate ligament
- Medical subject headings
- Femoral Neuropathy, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
Also called ANY
The femoral nerve block will be performed with ultrasound 30 minutes before the intervention
PCA morphineProcedure or surgery
Also called ANY
Postoperative analgesia with self-administration iv morphine
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Active comparator | Continuous femoral nerve block with bolus of ropivacaine 0.5% and then continuous infusion of ropivacaine 0.2 % 4 - 6 ml/h, associated with paracetamol and ibuprofen. Each group will contain 30 patients. Receives: Procedure: Femoral nerve block |
| PCA morphine | Placebo comparator | Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen. Receives: Procedure: PCA morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of femoral neuropathy
Clinical neurological exam (diminished or absent patellar reflex, or sensory loss in the femoral nerve territory) and ENMG (Axon loss ratio, Hofmann reflex, coumpound muscle action potentials, any fibrillation potentials of the muscle at rest) at 6 postoperative weeks. A control will be done at 3 months if a neuropathy is present.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral NeuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, MD, Principal investigator, Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321138
- Sponsor's protocol ID
- CHUV-75-10
- Status last verified
- Nov 2015
- First submitted
- 22 Mar 2011
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stebler K, Martin R, Kirkham KR, Kuntzer T, Bathory I, Albrecht E. Electrophysiological Study of Femoral Nerve Function After a Continuous Femoral Nerve Block for Anterior Cruciate Ligament Reconstruction: A Randomized, Controlled Single-Blind Trial. Am J Sports Med. 2017 Mar;45(3):578-583. doi: 10.1177/0363546516669715. Epub 2016 Nov 13.
PubMed 27836905
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)
- ClinicalTrials.gov ID
- NCT01321138
- Acronym / sponsor ID
- CHUV-75-10
- Conditions
- Femoral Neuropathy
- Keywords
- Electrophysiological study, Nerve block, Analgesia, Patient-Controlled, Anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Mar 2011 (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.
Femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block may be as high as 24% at 6 postoperative weeks when evaluated prospectively and systematically through a clinical neurological and an electroneuromyography (ENMG). It is still unclear whether this neuropathy is the result of the surgery, especially the Tourniquet, or the block nerve. The goal of this study is to define the etiology of this postoperative neuropathy.
Detailed description
Anterior cruciate ligament reconstruction is associated with moderate to severe postoperative pain. Among different analgesic strategies, continuous femoral nerve block is reported as an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients, particularly on athletes who need immediate rehabilitation and who will put their knee to greater use during the postoperative period. This study is designed to compare the incidence of femoral neuropathy in two groups of patients: one with a femoral nerve block, and one with a PCA of morphine (self-iv administration of morphine). All patients will have a clinical neurological exam with a preoperative ENMG in order to rule out a pre-existing neuropathy. Another clinical neurological exam with ENMG will be performed between 4 and 6 weeks and, if pathological, repeated at 6 months, 9 months and 12 months. The operation will be done under general anesthesia for all patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Active comparator | Procedure: Femoral nerve blockContinuous femoral nerve block with bolus of ropivacaine 0.5% and then continuous infusion of ropivacaine 0.2 % 4 - 6 ml/h, associated with paracetamol and ibuprofen. Each group will contain 30 patients. |
| PCA morphine | Placebo comparator | Procedure: PCA morphinePatients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients planned for anterior cruciate ligament reconstruction
- ASA 1 and 2
- age 16 years and more
Key exclusion criteria (7 listed)
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
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 blockAlso: ANYThe femoral nerve block will be performed with ultrasound 30 minutes before the intervention | Procedure or surgery | Femoral nerve block |
| PCA morphineAlso: ANYPostoperative analgesia with self-administration iv morphine | Procedure or surgery | PCA morphine |
Primary outcome
Incidence of femoral neuropathy
Time frame: 6 weeks
Clinical neurological exam (diminished or absent patellar reflex, or sensory loss in the femoral nerve territory) and ENMG (Axon loss ratio, Hofmann reflex, coumpound muscle action potentials, any fibrillation potentials of the muscle at rest) at 6 postoperative weeks. A control will be done at 3 months if a neuropathy is present.
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 30 Nov 2015.
- Derived from this study: PubMed 27836905Stebler K, Martin R, Kirkham KR, Kuntzer T, Bathory I, Albrecht E. Electrophysiological Study of Femoral Nerve Function After a Continuous Femoral Nerve Block for Anterior Cruciate Ligament Reconstruction: A Randomized, Controlled Single-Blind Trial. Am J Sports Med. 2017 Mar;45(3):578-583. doi: 10.1177/0363546516669715. Epub 2016 Nov 13.
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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.
Eric Albrecht, MD principal investigator
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block and PCA morphine in people with Femoral Neuropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 inclusion and 7 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 30 Nov 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Incidence of femoral neuropathy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321138, which also lists 1 linked publication.
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 30 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.