Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery (COMBAX)

December 20, 2011 updated by: University Hospital, Brest

Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Brittany
      • Brest, Brittany, France, 29200
        • Department of Anesthesia CHRU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 40 ml of Xylocaine
Drug: Xylocaine
40 ml or 25 ml of Xylocaine injection
Experimental: 25 ml of Xylocaine
Drug: Xylocaine
40 ml or 25 ml of Xylocaine injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: François PICART, MD, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB09-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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