Continuous Regional Analgesia After Total Knee Arthroplasty

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00337597
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Duration (Months): 19
• Patients Per Site: 25
• Patients Per Site Per Month: 1.3

Study Details

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.

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 Design

• Study Type: Interventional
• 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 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

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 [during 48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Departemental Hospital of la Roche sur Yon	La Roche sur Yon		France	85000
2	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Charles Pham Dang, MD, Nantes UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00337597
• Other Study ID Numbers: BRD 05/7-F
• First Posted: Jun 16, 2006
• Last Update Posted: Jul 21, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Normal saline; Dextrose 5% in water; neurostimulation; Continuous regional analgesia after total knee arthroplasty
• Additional relevant MeSH terms: Agnosia

Study Results

No Results Posted as of Jul 21, 2008