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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216488
First received: October 5, 2010
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Forearm and Arm Surgery
 Drug: Xylocaine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Axillary block efficiency conducted by ultrasound [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    during the hospitalisation


Enrollment: 72
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216488

Locations
France
Department of Anesthesia CHRU Brest
Brest, Brittany, France, 29200
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: François PICART, MD CHRU Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01216488     History of Changes
Other Study ID Numbers: RB09-060
Study First Received: October 5, 2010
Last Updated: December 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Forearm surgery
Hand surgery
Anesthesia

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013