Continuous Regional Analgesia After Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Other: NaCl 0.9%; Other: Glucose 5%

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
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • La Roche sur Yon, France, 85000
    • Departemental Hospital of la Roche sur Yon
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy of post-operative analgesia	during 48 hours

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Charles Pham Dang, MD, Nantes UH

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 15, 2006
• First Submitted That Met QC Criteria: June 15, 2006
• First Posted (Estimate): June 16, 2006

Study Record Updates

• Last Update Posted (Estimate): July 21, 2008
• Last Update Submitted That Met QC Criteria: July 18, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: neurostimulation; Normal saline; Dextrose 5% in water; Continuous regional analgesia after total knee arthroplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: BRD 05/7-F