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A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313546
First Posted: March 11, 2011
Last Update Posted: March 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose

Objective: Continuous nerve block (freezing the nerve) is needed for knee replacement surgery to reduce pain, increase rehabilitation and discharge patients home fast. A lot of time, money and hospital resources are invested in inserting these catheters. The aim of this study is to compare two end points used for insertion of continuous femoral nerve block and to see which one results in fewer failures on the surgical ward.

Methodology: Patients having total knee replacement surgery will be recruited in this study. Patients will be randomized into two groups. The continuous femoral nerve block catheter will be inserted using ultrasound and nerve stimulation with two different end points (certain muscle contraction).

Patients will be followed on day 1 and 2 after surgery to observe which catheter fails, how much pain the patient suffers and how much painkiller the patients used.


Condition Intervention Phase
Arthroplasty, Replacement, Knee Other: Stimulation of quariceps muscle Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparison of Sartorius Vs. Quadriceps Evoked Motor Response for Femoral Nerve to Prevent Secondary Catheter Failure

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • the number of secondary catheter failures [ Time Frame: 12 months ]
    to prevent the occurance of failed femoral nerve catheter on postoperative day 1


Secondary Outcome Measures:
  • total morphine consumption [ Time Frame: 12 months ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: quadriceps
quadriceps muscular contraction
Other: Stimulation of quariceps muscle
stimulation of quadriceps muscle through the stimulating catheter
Other Names:
  • Medial stimulation
  • patellar twitches
Active Comparator: sartorius
stimulation of sartorius muscle through femoral nerve
Other: Stimulation of quariceps muscle
stimulation of quadriceps muscle through the stimulating catheter
Other Names:
  • Medial stimulation
  • patellar twitches

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having total knee arthroplasty AsA 1-3

Exclusion Criteria:

  • patients with a history of significant medical or psychiatric problems, BMI > 40, allergy to local anesthetic drugs, prior surgery in the inguinal region, neurological disease with sensory or motor deficit, and diabetic neuropathy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313546


Contacts
Contact: IMAD AWAD, MBChB 416 480 4864 imad.awad@sunnybrook.ca
Contact: colin MCCARTNEY, FRCPC

Locations
Canada, Ontario
The Holland orthopedic and arthritic centre Not yet recruiting
TOronto, Ontario, Canada
Contact: imad awad         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: imad Awad, FFARCSI Sunnybrook Hospital
  More Information

Responsible Party: Dr. Imad Awad, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01313546     History of Changes
Other Study ID Numbers: Sunnybrook_Women's
First Submitted: March 10, 2011
First Posted: March 11, 2011
Last Update Posted: March 11, 2011
Last Verified: March 2011

Keywords provided by Sunnybrook Health Sciences Centre:
Femoral nerve block
total knee arthroplasty