Continuous Saphenous Block Versus Continuous Femoral Block for Total Knee Arthroplasty

November 29, 2010 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

Continuous Saphenous Block Vs. Continuous Femoral Block for Total Knee Arthroplasty: Prospective, Randomized, Double Blind Study.

Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. We will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. The primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. The secondary outcome is the morphine consumption in the two groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis

Exclusion Criteria:

  • ASA 4-5
  • Abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia
  • Contraindications for spinal anesthesia
  • Morbid obesity
  • Organ transplant
  • Neuropathic pain
  • History of stroke or major neurological deficit
  • Sensory and motor disorders in the operated limb
  • Previous drug dependency
  • Chronic use of opioids
  • Allergy to local anesthetics
  • Inability to comprehend pain assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: femoral block
Procedure: continuous femoral nerve block
ultrasound guided femoral nerve catheter insertion.
Experimental: saphenous block
Procedure: continuous saphenous nerve block
ultrasound guided saphenous nerve catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to assess the functional capacity and the impact of each block on the ability to walk by measuring the distance (the 2 minute walk test) in post op day one in the two groups.
Time Frame: post op day one
post op day one

Secondary Outcome Measures

Outcome Measure
Time Frame
the morphine consumption in the two groups.
Time Frame: post op day one
post op day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: JF Asenjo, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-153-SDR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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