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

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ClinicalTrials.gov Identifier: NCT02438657
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief 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.


Condition or disease Intervention/treatment Phase
Surgery Procedure: median nerve block Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic
Study Start Date : May 2015
Estimated Primary Completion Date : November 3, 2018
Estimated Study Completion Date : November 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: lidocaine with epinephrine (20 mg/ml)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438657


Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Centre Hospitalier de la Côte Basque Recruiting
Bayonne, France, 64100
Contact: Eric Dufour, MD         
Hopital privé de l'Ouest Parisien Recruiting
Trappes, France, 78190
Contact: Souhail JAZIRI, MD         
Principal Investigator: Souhail JAZIRI, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Eric Dufour, MD Centre Hospitalier de la Côte Basque, 64100 Bayonne, France

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02438657     History of Changes
Other Study ID Numbers: 2014/07
2014-000571-50 ( EudraCT Number )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents