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

Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: median nerve block

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la côte Basque
  • Trappes, France, 78190
    • Hôpital Privé de l'Ouest Parisien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: median nerve block; 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)

Procedure: median nerve block; Other Names: lidocaine with epinephrine (20 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal effective volume of local anesthetic	Effective volume of local anesthetic to obtain a successful median nerve block block in 95% of patients defined as complete light touch block at the palmar aspect of the 2 distal phalanges of the index finger during a 30 minute evaluation period (mL)	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve block onset time	Onset time for complete cold light touch and motor block at 30 min and 45 min.	1 hour
Success rate of the median nerve block	Success rate concerns: success rate of sensitive block: complete cold and light touch block at 30 min and 45 min at the palmar aspect of the 2 distal phalanges of the index finger and on the thenar eminence; success rate of motor block: complete motor block at 30 min and 45 min	1 hour
Additional local anesthetic	Percentage of cases where additional local anesthetic was necessary before the incision (%), i.e; performed by anesthesiologist; Percentage of cases where additional local anesthetic was necessary after the incision (%), i.e; performed by surgeon	2 hours
Duration of analgesia	Time to first analgesic requirement (minutes)	1 day
Duration of the block	Delay between the completion of the block and the returned to normal onset of sensory and motor recovery of the first three fingers of the hand) (minutes)	1 day
Complications	complications occurring during the procedure (pain, paresthesia, intraneural injection and vascular puncture),; complications noticed at the first postoperative month (residual pain, paresthesia, dysesthesia, weakness)	1 month
Block procedure time	Time taken to perform hydrodissection with dextrose 5% and inject the local anesthetic (min)	One hour

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Eric Dufour, MD, Centre Hospitalier de la Côte Basque, 64100 Bayonne, France

Publications and helpful links

General Publications

• Dufour E, Jaziri S, Novillo MA, Aubert L, Chambon A, Kutz R, Vallee A, Fischler M. A randomized trial to determine the minimum effective lidocaine volume for median nerve block using hydrodissection. Sci Rep. 2022 Jan 7;12(1):52. doi: 10.1038/s41598-021-03660-7.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine
• Other Study ID Numbers: 2014/07; 2014-000571-50 (EudraCT Number)