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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01250041
Other study ID # 10-153-SDR
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2010
Last updated November 29, 2010
Start date January 2011
Est. completion date December 2011

Study information

Verified date November 2010
Source McGill University Health Center
Contact JF Asengo, MD
Phone (514) 934-1934
Email jfasenjog@yahoo.com
Is FDA regulated No
Health authority Canada: MUHC
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)


Related Conditions & MeSH terms

  • Total Knee Arthroplasty Secondary to Osteoarthritis

Intervention

Procedure:
continuous femoral nerve block
ultrasound guided femoral nerve catheter insertion.
continuous saphenous nerve block
ultrasound guided saphenous nerve catheter insertion

Locations

Country Name City State
Canada Montreal General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. post op day one No
Secondary the morphine consumption in the two groups. post op day one No