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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chicago Anesthesia Pain Specialists
Sponsor:
Information provided by (Responsible Party):
Antony Tharian, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier:
NCT01763814
First received: January 2, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention
Knee Arthroplasty
Procedure: Femoral nerve block
Procedure: Femoral nerve block non stimulating catheter
Procedure: Femoral nerve block stimulating catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • Change in the Numeric Rating Pain Score [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
    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:
  • Change in the ability to move the knee [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
    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.

  • Change in Supplemental pain medications [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
    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:
  • Change in the overall satisfaction [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763814

Contacts
Contact: N. Nick Knezevic, M.D., Ph. D. 773-296-7927 aimmc.anesthesia.research@gmail.com

Locations
United States, Illinois
Chicago Anesthesia Pain Specialists Recruiting
Chicago, Illinois, United States, 60657
Contact: N. Nick Knezevic, M.D., Ph.D.    773-296-7927    aimmc.anesthesia.research@gmail.com   
Principal Investigator: Antony R Tharian, MD         
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
Principal Investigator: Antony Tharian, M.D. Chicago Anesthesia Pain Specialists
  More Information

No publications provided

Responsible Party: Antony Tharian, MD, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01763814     History of Changes
Other Study ID Numbers: Advocate-IRB-5235
Study First Received: January 2, 2013
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014