Continuous Regional Analgesia After Total Knee Arthroplasty

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337597
• Other study ID #: BRD 05/7-F
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2006
• Last updated: July 18, 2008
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• Glucose 5%

• NaCl 0.9%

Locations

Country	Name	City	State
France	Departemental Hospital of la Roche sur Yon	La Roche sur Yon
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter
Secondary	Efficacy of post-operative analgesia		during 48 hours