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

NCT ID: NCT01321138

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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

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Femoral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type PROCEDURE

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

PCA morphine

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

Group Type PLACEBO_COMPARATOR

PCA morphine

Intervention Type PROCEDURE

Postoperative analgesia with self-administration iv morphine

Interventions

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Femoral nerve block

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

Intervention Type PROCEDURE

PCA morphine

Postoperative analgesia with self-administration iv morphine

Intervention Type PROCEDURE

Other Intervention Names

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ANY ANY

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Eric Albrecht

Chef de Clinique

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Locations

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Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 27836905 (View on PubMed)

Other Identifiers

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CHUV-75-10

Identifier Type: -

Identifier Source: org_study_id