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

Not Applicable

Completed

• Conditions: Femoral Neuropathy
• Interventions: Procedure: Femoral nerve block; Procedure: PCA morphine

• Registration Number: NCT01321138
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-04
• Primary Completion: 2014-11
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block	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.
PCA morphine	PCA morphine	Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen.

Primary Outcome Measures

Name	Time	Method
Incidence of femoral neuropathy	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland