Ultrasound Guided Femoral Nerve Block and Ultrasound Guided Femoral Nerve Block With Peripheral Nerve Stimulation in Knee Replacement Surgery - Full Text View

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:	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:

MedlinePlus related topics: Knee Replacement Ultrasound

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

catheter insertion technique comparison [ Time Frame: 4 years ] [ Designated as safety issue: No ]
determine optimal technique for ultrasound guided placement of nerve catheters

Secondary Outcome Measures:

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

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
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

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, 44195

Sponsors and Collaborators

Outcomes Research Consortium

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 M.D., Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00927368 History of Changes
Other Study ID Numbers:	09-340
Study First Received:	June 24, 2009
Last Updated:	August 31, 2011
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 09, 2012