NCT01250041

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

November 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

November 26, 2010

Last Update Submit

November 29, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • the morphine consumption in the two groups.

    post op day one

Study Arms (2)

femoral block

ACTIVE COMPARATOR
Procedure: continuous femoral nerve block

saphenous block

EXPERIMENTAL
Procedure: continuous saphenous nerve block

Interventions

ultrasound guided femoral nerve catheter insertion.

femoral block

ultrasound guided saphenous nerve catheter insertion

saphenous block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Study Officials

  • JF Asenjo, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2010

First Posted

November 30, 2010

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations