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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02438657
• Date of registration: 06/05/2015
• Prospective Registration: Yes
• Primary sponsor: Hopital Foch
• Public title: Ultrasound-guided Nerve Block: Determination of the Minimal Effective Volume of Local Anesthetic VMAL
• Scientific title: Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic
• Date of first enrolment: May 21, 2015
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02438657
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Eric Dufour, MD
• Affiliation: Centre Hospitalier de la Côte Basque, 64100 Bayonne, France

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Surgery

Intervention(s)

Procedure: median nerve block

Primary Outcome(s)

Minimal effective volume of local anesthetic [Time Frame: 1 hour]

Secondary Outcome(s)

Additional local anesthetic [Time Frame: 2 hours]

Duration of the block [Time Frame: 1 day]

Block procedure time [Time Frame: One hour]

Complications [Time Frame: 1 month]

Nerve block onset time [Time Frame: 1 hour]

Success rate of the median nerve block [Time Frame: 1 hour]

Duration of analgesia [Time Frame: 1 day]

Secondary ID(s)

2014-000571-50

2014/07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors