Efficacy of Median Nerve Block Performed Using Echographi... | NCT00835653

Studies
Efficacy of Median Nerve Block Performed Using Echographic Guidance

NCT00835653

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Sep 23, 2016Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Orthopedic

Interventions

median nerve block
median nerve block

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Feb 2, 2009

First Submission Date that Met QC Criteria

Feb 2, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2016

Last Update Posted Date

Sep 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients with a carpal tunnel syndrome	Procedure: median nerve block
2		patients without a carpal tunnel syndrome	Procedure: median nerve block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
median nerve block	Procedure	median nerve block performed under echographic guidance	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
light touch sensibility		30 minutes following block performance

Secondary Outcomes

Measure	Description	Time Frame
ice touch sensibility		30 minutes following block performance
motor block		30 minutes following block performance
paresthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients scheduled for hand surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, MD	Hopital Foch	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92150	France
Hôpital Privé de l'Ouest Parisien