Descriptive Assessment of Practice in Anaesthesia : Lidoc... | NCT03290404

Studies
Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization

NCT03290404

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

292Actual

Phase

Not provided

Conditions

Axillary Block

Interventions

Not provided

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

Nov 2017

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

Nov 13, 2017Actual

Primary Completion Date

Mar 19, 2018Actual

Completion Date

Mar 19, 2018Actual

First Submitted Date

Sep 19, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 21, 2017Actual

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

Apr 5, 2018

Last Update Posted Date

Apr 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL).

The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks.

No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block.

The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

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

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

292Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resort to an anesthesia for help in case of ineffectiveness of the block	Yes or no Yes or No	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Block depth	Bromage score	Day 1

Other Outcomes

Measure	Description	Time Frame
Time of Block	Minutes	Day 1
Total dose of Lidocaïne adrenaline used	mg	Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients operated for the upper limb under block axillaire
Adult
non-opposition

Exclusion Criteria:

medical advice to realize axillary block
medical advice to local anaesthetic
Allergy
Pregnant
ASA 3 or more

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

Adult operated for the upper limb under block axillaire

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Instruction des Armées		Brest		29200	France
CHRU de Brest