Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery

NCT ID: NCT01216488

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Forearm and Arm Surgery

Keywords

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Forearm surgery Hand surgery Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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40 ml of Xylocaine

Group Type ACTIVE_COMPARATOR

Xylocaine

Intervention Type DRUG

40 ml or 25 ml of Xylocaine injection

25 ml of Xylocaine

Group Type EXPERIMENTAL

Xylocaine

Intervention Type DRUG

40 ml or 25 ml of Xylocaine injection

Interventions

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Xylocaine

40 ml or 25 ml of Xylocaine injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François PICART, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

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Department of Anesthesia CHRU Brest

Brest, Brittany Region, France

Site Status

Countries

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France

Other Identifiers

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RB09-060

Identifier Type: -

Identifier Source: org_study_id