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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ehab Farag, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00927368
First received: June 24, 2009
Last updated: December 18, 2013
Last verified: January 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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 The Cleveland Clinic:

Primary Outcome Measures:
  • catheter insertion technique comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To compare the secondary failure of the femoral nerve catheter inserted by three different technique using ultrasound guided placement of nerve catheters. Secondary failure of the catheter is measured jointly by both pain scores and opioid requirements.


Secondary Outcome Measures:
  • pain assessment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Block performance time, block failure rate, number of sciatic nerve blocks, and cost of the femoral nerve blockade procedures


Estimated Enrollment: 420
Study Start Date: July 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: stimulation needle and stimulating catheter
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
Active Comparator: nerve catheter with stimulating needle
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
Active Comparator: femoral nerve block without stimulation
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
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: NCT00927368

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Ehab Farag, M.D. The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Ehab Farag, Principal Investigator, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00927368     History of Changes
Other Study ID Numbers: 09-340
Study First Received: June 24, 2009
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
TKA
total knee replacement
stimulating nerve catheters

ClinicalTrials.gov processed this record on October 23, 2014