Clinical Trials Directory

Trials / Completed

CompletedNCT01321138

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Centre Hospitalier Universitaire Vaudois · Academic / Other
Sex
All
Age
16 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREFemoral nerve blockThe femoral nerve block will be performed with ultrasound 30 minutes before the intervention
PROCEDUREPCA morphinePostoperative analgesia with self-administration iv morphine

Timeline

Start date
2011-04-01
Primary completion
2014-11-01
Completion
2015-11-01
First posted
2011-03-23
Last updated
2015-11-30

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01321138. Inclusion in this directory is not an endorsement.