Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
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|ClinicalTrials.gov Identifier: NCT01321138|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neuropathy||Procedure: Femoral nerve block Procedure: PCA morphine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2015|
Active Comparator: Femoral nerve block
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.
Procedure: Femoral nerve block
The femoral nerve block will be performed with ultrasound 30 minutes before the intervention
Other Name: ANY
Placebo Comparator: PCA morphine
Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen.
Procedure: PCA morphine
Postoperative analgesia with self-administration iv morphine
Other Name: ANY
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321138
|Centre Hospitalier Universitaire Vaudois and University of Lausanne|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||Eric Albrecht, MD||Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne|