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OpenTrials
Completed

NCT Number: NCT01216488

Comparison Between Two Different Volumes of Anesthesia Drug in Forearm 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesia CHRU Brest

Brest, Brittany Region, 29200, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylocaine

Drug

40 ml or 25 ml of Xylocaine injection

Primary outcomes

  1. Axillary block efficiency conducted by ultrasound

    Time frame: 48 hours

    during the hospitalisation

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: COMBAX

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 7, 2010
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.