NCT03290404

Brief Summary

Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL). The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks. No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block. The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

April 6, 2018

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

September 19, 2017

Last Update Submit

April 5, 2018

Conditions

Axillary Block

Keywords

Axillary BlockLidocaÏne 1% adrenaliné

Outcome Measures

Primary Outcomes (1)

  • Resort to an anesthesia for help in case of ineffectiveness of the block

    Yes or no Yes or No

    Day 1

Secondary Outcomes (1)

  • Block depth

    Day 1

Other Outcomes (3)

  • Time of Block

    Day 1

  • Total dose of Lidocaïne adrenaline used

    Day 1

  • Patient satisfaction

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult operated for the upper limb under block axillaire

You may qualify if:

  • Patients operated for the upper limb under block axillaire
  • Adult
  • non-opposition

You may not qualify if:

  • medical advice to realize axillary block
  • medical advice to local anaesthetic
  • Allergy
  • Pregnant
  • ASA 3 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Instruction des Armées

Brest, 29200, France

Location

CHRU de Brest

Brest, 29609, France

Location

Centre Hospitalier Intercommunal de Cornouaille

Quimper, 29017, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 21, 2017

Study Start

November 13, 2017

Primary Completion

March 19, 2018

Study Completion

March 19, 2018

Last Updated

April 6, 2018

Record last verified: 2017-11

Locations

FR(3)