Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Femoral Neuropathy |
Procedure: Femoral nerve block Procedure: PCA morphine |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- patients planned for anterior cruciate ligament reconstruction
- ASA 1 and 2
- age 16 years and more
Exclusion Criteria:
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
- cancer with chemotherapy
- chronic pain state
Contacts and Locations| Contact: Eric Albrecht, MD | +41795566341 | eric.albrecht@chuv.ch |
| Contact: Istvan Bathory, MD | +41795565312 | istvan.bathory@chuv.ch |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois and University of Lausanne | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Eric Albrecht, MD +41795566341 eric.albrecht@chuv.ch | |
| Contact: Istvan Bathory, MD +41795565312 istvan.bathory@chuv.ch | |
| Principal Investigator: | Eric Albrecht, MD | Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne |
More Information
No publications provided
| Responsible Party: | Eric Albrecht, Chef de Clinique, Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT01321138 History of Changes |
| Other Study ID Numbers: | CHUV-75-10 |
| Study First Received: | March 22, 2011 |
| Last Updated: | November 2, 2012 |
| Health Authority: | Switzerland: Laws and standards |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
|
Electrophysiological study Nerve block Analgesia, Patient-Controlled Anterior cruciate ligament |
Additional relevant MeSH terms:
|
Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Femoral Neuropathy Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
Mononeuropathies Morphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013