Continuous Regional Analgesia After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00337597
First received: June 15, 2006
Last updated: July 18, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Analgesia
Other: Glucose 5%
Other: NaCl 0.9%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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

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

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Charles Pham Dang, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00337597     History of Changes
Other Study ID Numbers: BRD 05/7-F
Study First Received: June 15, 2006
Last Updated: July 18, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 22, 2014