Full Text View
Tabular View
No Study Results Posted
Related Studies
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 by Outcomes Research Consortium, December 2009
First Received: June 24, 2009   Last Updated: December 15, 2009   History of Changes
Sponsor: Outcomes Research Consortium
Information provided by: Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00927368
  Purpose

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.


Condition Intervention
Total Knee Replacement Surgery
Procedure: stimulation needle and stimulating catheter
Procedure: nerve catheter with stimulating needle
Procedure: guided femoral nerve block without stimulation

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • determine optimal technique for ultrasound guided placement of nerve catheters [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain assessment post operative as compared to nerve block technique [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: July 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
stimulation needle and stimulating catheter: Active Comparator
ultrasound guided femoral nerve catheter using a stimulation needle and a stimulating catheter
Procedure: stimulation needle and stimulating catheter
ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter
nerve catheter with stimulating needle: Active Comparator
ultrasound guided femoral nerve catheter using a stimulation needle but non stimulating catheter
Procedure: nerve catheter with stimulating needle
Ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter
femoral nerve block without stimulation: Active Comparator
ultrasound guided femoral nerve block without stimulation
Procedure: guided femoral nerve block without stimulation
ultrasound guided femoral nerve block without stimulation.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927368

Contacts
Contact: Ehab Farag, M.D. 216-445-7550 farage@ccf.org
Contact: Gretchen A Upton 216-444-3289 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Ehab Farag, M.D. Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. Cleveland Clinic
  More Information

No publications provided

Responsible Party: Cleveland Clinic ( Ehab Farag M.D. )
Study ID Numbers: 09-340
Study First Received: June 24, 2009
Last Updated: December 15, 2009
ClinicalTrials.gov Identifier: NCT00927368     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
TKA
total knee replacement
stimulating nerve catheters

ClinicalTrials.gov processed this record on February 08, 2010