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Efficacy of Median Nerve Block Performed Using Echographic Guidance

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00835653
First received: February 2, 2009
Last updated: May 27, 2009
Last verified: May 2009
History of Changes
  Purpose

Observational study of the efficacy of median nerve blocks performed using echographic guidance in patients presenting with or without carpal tunnel syndrome.


Condition Intervention
Orthopedic
 Procedure: median nerve block

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Median Nerve Block Performed Using Echographic Guidance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • light touch sensibility [ Time Frame: 30 minutes following block performance ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ice touch sensibility [ Time Frame: 30 minutes following block performance ] [ Designated as safety issue: No ]
  • motor block [ Time Frame: 30 minutes following block performance ] [ Designated as safety issue: No ]
  • paresthesia [ Time Frame: during nerve block procedure ] [ Designated as safety issue: Yes ]
  • vascular puncture [ Time Frame: during nerve block procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
patients with a carpal tunnel syndrome
 Procedure: median nerve block
median nerve block performed under echographic guidance
2
patients without a carpal tunnel syndrome
 Procedure: median nerve block
median nerve block performed under echographic guidance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients scheduled for hand surgery

Criteria

Inclusion Criteria:

  • short surgical procedure (less than 30 minutes) on the hand,
  • regional anesthesia at the elbow involving the median nerve.

Exclusion Criteria:

  • age less than 18 years,
  • pregnant woman
  • mental incapacity,
  • poor understanding of French.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835653

Locations
France
Hopital Foch
Suresnes, France, 92150
Hôpital Privé de l'Ouest Parisien
Trappes, France, 78190
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00835653     History of Changes
Other Study ID Numbers: 2008/42
Study First Received: February 2, 2009
Last Updated: May 27, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 19, 2013