NCT01321138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

3.6 years

First QC Date

March 22, 2011

Last Update Submit

November 25, 2015

Conditions

Femoral Neuropathy

Keywords

Electrophysiological studyNerve blockAnalgesia, Patient-ControlledAnterior cruciate ligament

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

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

PCA morphine

PLACEBO COMPARATOR

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

Procedure: PCA morphine

Interventions

Femoral nerve blockPROCEDURE

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

Also known as: ANY
Femoral nerve block
PCA morphinePROCEDURE

Postoperative analgesia with self-administration iv morphine

Also known as: ANY
PCA morphine

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients planned for anterior cruciate ligament reconstruction
  • ASA 1 and 2
  • age 16 years and more

You may not qualify if:

  • peripheral neuropathy
  • pre-existing femoral neuropathy
  • diabetes mellitus
  • alcoholism
  • drug addiction
  • cancer with chemotherapy
  • chronic pain state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27836905DERIVED

MeSH Terms

Conditions

Femoral NeuropathyAgnosia

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Albrecht, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

CH(1)