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Completed

NCT Number: NCT02438657

Ultrasound-guided Nerve Block: 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.

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Key information

Conditions

Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre Hospitalier de la Côte Basque, Bayonne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Median Nerve Block

Procedure

Other names: lidocaine with epinephrine (20 mg/ml)

Primary outcomes

  1. Minimal effective volume of local anesthetic

    Time frame: 1 hour

    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)

Secondary outcomes

  1. Nerve block onset time

    Time frame: 1 hour

    Onset time for complete cold light touch and motor block at 30 min and 45 min.

  2. Success rate of the median nerve block

    Time frame: 1 hour

    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

  3. Additional local anesthetic

    Time frame: 2 hours

    • 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

  4. Duration of analgesia

    Time frame: 1 day

    Time to first analgesic requirement (minutes)

  5. Duration of the block

    Time frame: 1 day

    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)

  6. Complications

    Time frame: 1 month

    • complications occurring during the procedure (pain, paresthesia, intraneural injection and vascular puncture),
    • complications noticed at the first postoperative month (residual pain, paresthesia, dysesthesia, weakness)

  7. Block procedure time

    Time frame: One hour

    Time taken to perform hydrodissection with dextrose 5% and inject the local anesthetic (min)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: VMAL

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 8, 2015
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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