Clinical trial NCT01321138: Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction: Femoral Nerve Block vs Patient-controlled Analgesia (PCA)
Official title: Comparison of Incidence of Femoral Neuropathy After Anterior Cruciate Ligament Reconstruction With Femoral Nerve Block Versus Patient-controlled Analgesia (PCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neuropathy
Keywords: Electrophysiological study
Nerve block
Analgesia, Patient-Controlled
Anterior cruciate ligament
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Incidence of femoral neuropathy
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
affiliation: Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
name: Eric Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stebler K, Martin R, Kirkham KR, Kuntzer T, Bathory I, Albrecht E. Electrophysiological Study of Femoral Nerve Function After a Continuous Femoral Nerve Block for Anterior Cruciate Ligament Reconstruction: A Randomized, Controlled Single-Blind Trial. Am J Sports Med. 2017 Mar;45(3):578-583. doi: 10.1177/0363546516669715. Epub 2016 Nov 13.