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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01321138
Other study ID # CHUV-75-10
Secondary ID
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


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
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