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
  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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: March 2015 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321138

Contacts
Contact: Eric Albrecht, MD +41795566341 eric.albrecht@chuv.ch
Contact: Istvan Bathory, MD +41795565312 istvan.bathory@chuv.ch

Locations
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   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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: February 26, 2014
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:
Femoral Neuropathy
Mononeuropathies
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014