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Continuous Regional Analgesia After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00337597
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : July 21, 2008
Sponsor:
Information provided by:
Nantes University Hospital

Brief Summary:
This prospective, comparative and double blind study is aimed to determine if normal saline or dextrose 5% in water will modify the stimulation during the insertion of the stimulating catheter used for continuous femoral and sciatic blocks in total knee replacement.

Condition or disease Intervention/treatment Phase
Analgesia Other: Glucose 5% Other: NaCl 0.9% Phase 3

Detailed Description:
The operator is blinded to the medium fluid to expand the perineural femoral and sciatic nerves before threading in the stimulating catheter. He records all the electric data of electrolocation of nerve, which will be compared to determine whether or not a difference in intensity is found between normal saline or dextrose 5% in water.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Regional Analgesia After Total Knee Arthroplasty. Normal Saline or Dextrose 5% in Water as Fluid Medium for Pre-Placement Expansion in Order to Facilitate the Catheter Passing
Study Start Date : May 2006
Primary Completion Date : July 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources




Primary Outcome Measures :
  1. Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter

Secondary Outcome Measures :
  1. Efficacy of post-operative analgesia [ Time Frame: during 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I and II
  • Male or non-pregnant female
  • 18 - 80 years of age
  • Not allergic to iodine or local anesthetics
  • Absence of abnormality of coagulation
  • Scheduled for total knee replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337597


Locations
France
Departemental Hospital of la Roche sur Yon
La Roche sur Yon, France, 85000
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Charles Pham Dang, MD Nantes UH

Responsible Party: Charles Pham Dang, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00337597     History of Changes
Other Study ID Numbers: BRD 05/7-F
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by Nantes University Hospital:
Normal saline
Dextrose 5% in water
neurostimulation
Continuous regional analgesia after total knee arthroplasty

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms