Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321138
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 30, 2015
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Brief 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). 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 or disease Intervention/treatment Phase
Femoral Neuropathy Procedure: Femoral nerve block Procedure: PCA morphine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : April 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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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 identifier (NCT number): NCT01321138

Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Principal Investigator: Eric Albrecht, MD Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eric Albrecht, Chef de Clinique, Centre Hospitalier Universitaire Vaudois Identifier: NCT01321138     History of Changes
Other Study ID Numbers: CHUV-75-10
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Eric Albrecht, Centre Hospitalier Universitaire Vaudois:
Electrophysiological study
Nerve block
Analgesia, Patient-Controlled
Anterior cruciate ligament

Additional relevant MeSH terms:
Femoral Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents