Back to resultsContinuous Regional Analgesia After Total Knee Arthroplasty
Primary Purpose
Analgesia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Glucose 5%
NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring Normal saline, Dextrose 5% in water, neurostimulation, Continuous regional analgesia after total knee arthroplasty
Eligibility 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
Sites / Locations
- Departemental Hospital of la Roche sur Yon
- Nantes University Hospital
Outcomes
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
Full Information
NCT ID
NCT00337597
First Posted
June 15, 2006
Last Updated
July 18, 2008
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00337597
Brief Title
Continuous Regional Analgesia After Total Knee Arthroplasty
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 Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Normal saline, Dextrose 5% in water, neurostimulation, Continuous regional analgesia after total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Glucose 5%
Intervention Type
Other
Intervention Name(s)
NaCl 0.9%
Primary Outcome Measure Information:
Title
Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter
Secondary Outcome Measure Information:
Title
Efficacy of post-operative analgesia
Time Frame
during 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Pham Dang, MD
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departemental Hospital of la Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Continuous Regional Analgesia After Total Knee Arthroplasty
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