NCT00337597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 21, 2008

Status Verified

July 1, 2008

Enrollment Period

1.2 years

First QC Date

June 15, 2006

Last Update Submit

July 18, 2008

Conditions

Analgesia

Keywords

Normal salineDextrose 5% in waterneurostimulationContinuous regional analgesia after total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Efficacy of post-operative analgesia

    during 48 hours

Interventions

Glucose 5%OTHER
NaCl 0.9%OTHER

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) I and II
  • Male or non-pregnant female
  • years of age
  • Not allergic to iodine or local anesthetics
  • Absence of abnormality of coagulation
  • Scheduled for total knee replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departemental Hospital of la Roche sur Yon

La Roche-sur-Yon, 85000, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Charles Pham Dang, MD

    Nantes UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

December 1, 2007

Last Updated

July 21, 2008

Record last verified: 2008-07

Locations

FR(2)