NCT01216488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

October 5, 2010

Last Update Submit

December 20, 2011

Conditions

Forearm and Arm Surgery

Keywords

Forearm surgeryHand surgeryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Axillary block efficiency conducted by ultrasound

    during the hospitalisation

    48 hours

Study Arms (2)

40 ml of Xylocaine

ACTIVE COMPARATOR
Drug: Xylocaine

25 ml of Xylocaine

EXPERIMENTAL
Drug: Xylocaine

Interventions

XylocaineDRUG

40 ml or 25 ml of Xylocaine injection

25 ml of Xylocaine40 ml of Xylocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia CHRU Brest

Brest, Brittany Region, 29200, France

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • François PICART, MD

    CHRU Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 7, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations

FR(1)