Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)|
- Incidence of femoral neuropathy [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321138
|Contact: Eric Albrecht, MDemail@example.com|
|Contact: Istvan Bathory, MDfirstname.lastname@example.org|
|Centre Hospitalier Universitaire Vaudois and University of Lausanne||Recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Eric Albrecht, MD +41795566341 email@example.com|
|Contact: Istvan Bathory, MD +41795565312 firstname.lastname@example.org|
|Principal Investigator:||Eric Albrecht, MD||Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne|