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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT01321138

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neuropathy	Procedure: Femoral nerve block Procedure: PCA morphine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Femoral nerve block The femoral nerve block will be performed with ultrasound 30 minutes before the intervention Other Names: ANY
Placebo Comparator: PCA morphine Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen.	Procedure: PCA morphine Postoperative analgesia with self-administration iv morphine Other Names: ANY

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Femoral nerve block

The femoral nerve block will be performed with ultrasound 30 minutes before the intervention

Other Names:

ANY

Placebo Comparator: PCA morphine

Patients with iv morphine with self administration with a PCA-system, associated with paracetamol and ibuprofen.

Procedure: PCA morphine

Postoperative analgesia with self-administration iv morphine

Other Names:

ANY

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

Principal Investigator: Eric Albrecht, MD, Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eric Albrecht, Chef de Clinique, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT01321138

Other Study ID Numbers:

CHUV-75-10

First Posted:

Mar 23, 2011

Last Update Posted:

Nov 30, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Eric Albrecht, Chef de Clinique, Centre Hospitalier Universitaire Vaudois

Electrophysiological study

Nerve block

Analgesia, Patient-Controlled

Anterior cruciate ligament

Additional relevant MeSH terms:

Femoral Neuropathy

Morphine

Study Results

No Results Posted as of Nov 30, 2015