Text Size

Continuous Saphenous Block Versus Continuous Femoral Block for Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01250041
First received: November 26, 2010
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Total Knee Arthroplasty Secondary to Osteoarthritis
 Procedure: continuous femoral nerve block
Procedure: continuous saphenous nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Continuous Saphenous Block Vs. Continuous Femoral Block for Total Knee Arthroplasty: Prospective, Randomized, Double Blind Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the morphine consumption in the two groups. [ Time Frame: post op day one ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250041

Contacts
Contact: JF Asengo, MD (514) 934-1934 ext 43261 jfasenjog@yahoo.com

Locations
Canada, Quebec
Montreal General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: JF Asenjo, MD     514) 934-1934 ext 43261     jfasenjog@yahoo.com    
Principal Investigator: JF Asenjo, MD            
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: JF Asenjo, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: JF Asenjo, MUHC
ClinicalTrials.gov Identifier: NCT01250041     History of Changes
Other Study ID Numbers: 10-153-SDR
Study First Received: November 26, 2010
Last Updated: November 29, 2010
Health Authority: Canada: MUHC

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013