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Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01763814
Recruitment Status : Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Antony Tharian, Chicago Anesthesia Pain Specialists

Brief Summary:
Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.

Condition or disease Intervention/treatment Phase
Knee Arthroplasty Procedure: Femoral nerve block Procedure: Femoral nerve block non stimulating catheter Procedure: Femoral nerve block stimulating catheter Not Applicable

Detailed Description:

This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:

Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Study Start Date : December 2011
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single shot femoral nerve block
A ultrasound probe will be used to identify the nerve, and correct needle placement.
Procedure: Femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.

Active Comparator: Femoral nerve block non stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.
Procedure: Femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.

Procedure: Femoral nerve block non stimulating catheter
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.

Active Comparator: Femoral nerve block stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.
Procedure: Femoral nerve block
A visible or palpable cephalad movement of the patella will confirm needle placement.

Procedure: Femoral nerve block stimulating catheter
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.




Primary Outcome Measures :
  1. Change in the Numeric Rating Pain Score [ Time Frame: Postoperative ]
    At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, 30 and 60 after the surgery.


Secondary Outcome Measures :
  1. Change in the ability to move the knee [ Time Frame: Postoperative ]
    At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, 30 and 60 after the surgery.

  2. Change in Supplemental pain medications [ Time Frame: Postoperative ]
    At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, 30 and 60 after the surgery.


Other Outcome Measures:
  1. Change in the overall satisfaction [ Time Frame: Postoperative ]
    At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, 30 and 60 after the surgery.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18- 90 years old
  • Scheduled for total knee arthroplasty

Exclusion Criteria:

  • Redo surgery on the same knee
  • BMI ≥45
  • Radicular pain in the same leg
  • Allergy to local anesthetics
  • Opioid habituation
  • Pregnancy
  • Contraindication to regional block
  • Inability to communicate with hospital staff or investigators.
  • Neuropathy of any etiology in the surgical extremity.

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): NCT01763814


Locations
United States, Illinois
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
Principal Investigator: Antony Tharian, M.D. Chicago Anesthesia Pain Specialists

Responsible Party: Antony Tharian, MD, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01763814     History of Changes
Other Study ID Numbers: Advocate-IRB-5235
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017