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SurgeryPhase 2/3VMALNCT02438657

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

A Phase 2/3 study testing median nerve block in people with Surgery, run by Hopital Foch at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Surgery
What is being tested?
median nerve block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesFrance
Study dates
21 May 2015to 30 Nov 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • contra-indication to the administration of lidocaine, notably allergy
  • contra-indication to the administration of lidocaine with epinephrine
  • not speaking French
  • patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

  • Hopital privé de l'Ouest Parisien

    Trappes, 78190

Other trials in France

About this study

Official title: 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.

Conditions
Surgery
Being tested
median nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • median nerve blockProcedure or surgery

    Also called lidocaine with epinephrine (20 mg/ml)

Study groups in NCT02438657
Study groupRoleWhat they receive
median nerve blockExperimentalAn 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)
Receives: Procedure: median nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 hour

Secondary outcomes (7)

  1. Nerve block onset time

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

    Measured: 1 hour

  2. 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

    Measured: 1 hour

  3. 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

    Measured: 2 hours

  4. Duration of analgesia

    Time to first analgesic requirement (minutes)

    Measured: 1 day

  5. 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)

    Measured: 1 day

  6. 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)

    Measured: 1 month

  7. Block procedure time

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

    Measured: One hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study start21 May 2015
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Ascending dose model
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438657
Sponsor's protocol ID
2014/07
Other IDs
2014-000571-50, 2014
Acronym
VMAL
Status last verified
Jul 2020
First submitted
6 May 2015
Last updated
22 Jul 2020
Results posted
No
Data monitoring committee
No

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.

    PubMed 34996918

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing median nerve block in people with Surgery, run by Hopital Foch at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal effective volume of local anesthetic (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.

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