Comparison Between Two Different Volumes of Anesthesia Dr... | NCT01216488

Studies
Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery

NCT01216488

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Dec 21, 2011Estimated

Enrollment

72Actual

Phase

Phase 3

Conditions

Forearm and Arm Surgery

Interventions

Xylocaine

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

Dec 2011

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 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Oct 5, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

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

Dec 20, 2011

Last Update Posted Date

Dec 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.

The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Detailed Description

Inclusion criteria :

age > 18 years old
patient who must have a non emergency surgery of the forearm or the hand
ASA I or ASA II
informed consent
Ensured patient

Exclusion criteria :

pregnancy
respiratory insufficiency
cardiac insufficiency
hepatic insufficiency
renal insufficiency
ASA III or IV
contraindications to the locoregional anesthesia
contraindications to the xylocaine used
patient participate to an another clinical study
guardianship patient

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
40 ml of Xylocaine	Active Comparator		Drug: Xylocaine
25 ml of Xylocaine	Experimental		Drug: Xylocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xylocaine	Drug	40 ml or 25 ml of Xylocaine injection	25 ml of Xylocaine 40 ml of Xylocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axillary block efficiency conducted by ultrasound	during the hospitalisation	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years old
patient who must have a non emergency surgery of the forearm or the hand
ASA I or ASA II
informed consent
Ensured patient

Exclusion Criteria:

pregnancy
respiratory insufficiency
cardiac insufficiency
hepatic insufficiency
renal insufficiency
ASA III or IV
contraindications to the locoregional anesthesia
contraindications to the xylocaine used
patient participate to an another clinical study
guardianship patient

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François PICART, MD	CHRU BREST	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia CHRU Brest		Brest	Brittany Region	29200	France

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided