NCT00835653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

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

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

February 2, 2009

Last Update Submit

September 22, 2016

Conditions

Orthopedic

Outcome Measures

Primary Outcomes (1)

  • light touch sensibility

    30 minutes following block performance

Secondary Outcomes (4)

  • ice touch sensibility

    30 minutes following block performance

  • motor block

    30 minutes following block performance

  • paresthesia

    during nerve block procedure

  • vascular puncture

    during nerve block procedure

Study Arms (2)

1

patients with a carpal tunnel syndrome

Procedure: median nerve block

2

patients without a carpal tunnel syndrome

Procedure: median nerve block

Interventions

median nerve blockPROCEDURE

median nerve block performed under echographic guidance

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for hand surgery

You may qualify if:

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

You may not qualify if:

  • age less than 18 years,
  • pregnant woman
  • mental incapacity,
  • poor understanding of French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Foch

Suresnes, 92150, France

Location

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

Location

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(2)