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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03290404
Other study ID # 29BRC17.0072 fLACON
Secondary ID
Status Completed
Phase
First received September 19, 2017
Last updated April 5, 2018
Start date November 13, 2017
Est. completion date March 19, 2018

Study information

Verified date November 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 292
Est. completion date March 19, 2018
Est. primary completion date March 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients operated for the upper limb under block axillaire

- Adult

- non-opposition

Exclusion Criteria:

- medical advice to realize axillary block

- medical advice to local anaesthetic

- Allergy

- Pregnant

- ASA 3 or more

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest
France Hôpital Instruction des Armées Brest
France Centre Hospitalier Intercommunal de Cornouaille Quimper

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Time of Block Minutes Day 1
Other Total dose of Lidocaïne adrenaline used mg Day 1
Other Patient satisfaction questionnaire score Day 1
Primary Resort to an anesthesia for help in case of ineffectiveness of the block Yes or no Yes or No Day 1
Secondary Block depth Bromage score Day 1