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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01321138
First received: March 22, 2011
Last updated: February 26, 2014
Last verified: February 2014

March 22, 2011
February 26, 2014
April 2011
March 2015   (final data collection date for primary outcome measure)
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.
Incidence of femoral neuropathy [ Time Frame: 6 weeks, 3 months, 6 months, 9 months, 12 months ] [ 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 various times points. The next appointment will be given to the patient only if there is still a neuropathy at the last exam.
Complete list of historical versions of study NCT01321138 on ClinicalTrials.gov Archive Site
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Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Femoral Neuropathy
  • Procedure: Femoral nerve block
    The femoral nerve block will be performed with ultrasound 30 minutes before the intervention
    Other Name: ANY
  • Procedure: PCA morphine
    Postoperative analgesia with self-administration iv morphine
    Other Name: ANY
  • 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.
    Intervention: Procedure: Femoral nerve block
  • Placebo Comparator: PCA morphine
    Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen.
    Intervention: Procedure: PCA morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
November 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
16 Years to 50 Years
Yes
Contact: Eric Albrecht, MD +41795566341 eric.albrecht@chuv.ch
Contact: Istvan Bathory, MD +41795565312 istvan.bathory@chuv.ch
Switzerland
 
NCT01321138
CHUV-75-10
No
Eric Albrecht, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Not Provided
Principal Investigator: Eric Albrecht, MD Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Centre Hospitalier Universitaire Vaudois
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP