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Ultrasound Guided Femoral Nerve Block and Ultrasound Guided Femoral Nerve Block With Peripheral Nerve Stimulation in Knee Replacement Surgery

This study is currently recruiting participants.
Verified August 2011 by Outcomes Research Consortium
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00927368
First received: June 24, 2009
Last updated: August 31, 2011
Last verified: August 2011
History of Changes

June 24, 2009
August 31, 2011
July 2009
May 2013   (final data collection date for primary outcome measure)
catheter insertion technique comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]
determine optimal technique for ultrasound guided placement of nerve catheters
determine optimal technique for ultrasound guided placement of nerve catheters [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00927368 on ClinicalTrials.gov Archive Site
pain assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
pain assessment post operative as compared to nerve block technique
pain assessment post operative as compared to nerve block technique [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ultrasound Guided Femoral Nerve Block and Ultrasound Guided Femoral Nerve Block With Peripheral Nerve Stimulation in Knee Replacement Surgery
Comparison Between Ultrasound Guided Femoral Nerve Block Versus Ultrasound Guided Femoral Nerve Block With the Use of Peripheral Nerve Stimulation for Patients Undergoing Total Knee Replacement.

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.

  • Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.
  • Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.
  • Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.
  • Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Total Knee Replacement Surgery
  • Procedure: stimulation needle and stimulating catheter
    ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter
  • Procedure: nerve catheter with stimulating needle
    Ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter
  • Procedure: guided femoral nerve block without stimulation
    ultrasound guided femoral nerve block without stimulation.
  • Active Comparator: stimulation needle and stimulating catheter
    ultrasound guided femoral nerve catheter using a stimulation needle and a stimulating catheter
    Intervention: Procedure: stimulation needle and stimulating catheter
  • Active Comparator: nerve catheter with stimulating needle
    ultrasound guided femoral nerve catheter using a stimulation needle but non stimulating catheter
    Intervention: Procedure: nerve catheter with stimulating needle
  • Active Comparator: femoral nerve block without stimulation
    ultrasound guided femoral nerve block without stimulation
    Intervention: Procedure: guided femoral nerve block without stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
May 2014
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 80 years old at time of surgery.
  • Male or female patients undergoing total knee replacement under either general or neuroaxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally.

Exclusion Criteria:

  • Current or recent drug abuse (within past 6 months).
  • Pregnancy.
  • Patient refuses regional analgesia.
Both
18 Years to 80 Years
No
Contact: Ehab Farag, M.D. 216-445-7550 farage@ccf.org
Contact: Gretchen A Upton 216-444-3289 uptong@ccf.org
United States
 
NCT00927368
09-340
No
Ehab Farag M.D., Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Ehab Farag, M.D. The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
Outcomes Research Consortium
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP