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

Femoral Neuropathy Clinical Trial

Official title:

Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321138
• Other study ID #: CHUV-75-10
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: November 25, 2015
• Start date: April 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Femoral Neuropathy

Intervention

Procedure:
• Femoral nerve block
The femoral nerve block will be performed with ultrasound 30 minutes before the intervention
• PCA morphine
Postoperative analgesia with self-administration iv morphine

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of femoral neuropathy	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.	6 weeks	Yes