Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic (VMAL)

Hopital Foch

Status and phase: Completed; Phase 3; Phase 2

Conditions: Surgery

Treatments: Procedure: median nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT02438657

2014-000571-50 (EudraCT Number)

2014/07

Details and patient eligibility

About

Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 18 years from 18 to 80 years with an ASA (American Society of Anesthesiologists) physical status I-II
• elective hand ambulatory surgery with a maximum duration of 30 minutes involving the median nerve and performed with elbow nerve blocks

Exclusion criteria

• pregnant or lactating women,
• contra-indication to regional anesthesia
• diabetes mellitus,
• effective anticoagulation or antiplatelet therapy, laboratory evidence of abnormal bleeding
• neurological disease ( including carpal tunnel syndrome or neuromuscular disease detected by preoperative neurological examination in the median nerve)
• infection at the puncture site
• contra-indication to the administration of lidocaine, notably allergy
• contra-indication to the administration of lidocaine with epinephrine
• not speaking French

Exclusion from the study:

• patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 1 patient group

median nerve block

Experimental group

Description:

An ultrasound-guided nerve block with dextrose 5% hydrodissection is performed in each case. The first patient will receive a 2 mL local anesthetic solution. For following patients, the volume of local anesthetic depends on the clinical result of the previous patient: * increase of the volume (0.5 mL) in case of failure, * no change or decrease (0.5 mol) in case of success; a randomization is made in this case (BCD method, Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics 2002;58:171-7)

Treatment:

Procedure: median nerve block