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NCT Number: NCT02940847

Ultrasound-guided Versus Blind Technique in Medial Brachial Cutaneous Nerve and Intercostobrachial Nerve Blocks

The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. The anesthesia of the posterior and the medial side of the arm requires a selective block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to achieve this block : the blind technique (without ultrasound) and the ultrasound-guided technique. At the moment, there are no studies which compare these two techniques. So, the purpose of this study is to determine the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial nerve block, in the axilla.

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Key information

Conditions

Upper Limb Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Nancy

Nancy, 54035, France

About this study

For purposes of this single-blind monocentric study, 84 patients are randomized into two groups (42 patients for each), upon enrolment into the study.

In the first group, the blind technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : it consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.

In the second group, the ultrasound-guided technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.

The aim is to evaluate the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercosto-brachial nerve block, in the axilla

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients ≥ 18 years
  • Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
  • Urgent or planned surgery
  • Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block
  • Local anesthetic used : mepivacaine 10mg/ml
  • In the absence of patient objections

Exclusion criteria

  • Pregnancy
  • Adults under guardianship
  • Locoregional anesthesia contraindications
  • Local anesthetic used : ropivacaine 0,75%

Treatment and study plan

medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique

Procedure

It consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.

medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique

Procedure

Ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.

Primary outcomes

  1. Number of participants with complete anesthesia in the lower half of the medial cutaneous area of the arm, at time 20 minutes

    Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block

    At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed

  2. Number of participants with complete anesthesia in the upper half of the medial cutaneous area of the arm, at time 20 minutes

    Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block

    At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed

  3. Number of participants with complete anesthesia in the lower half of the posterior cutaneous area of the arm, at time 20 minutes

    Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block

    At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed

  4. Number of participants with complete anesthesia in the upper half of the posterior cutaneous area of the arm, at time 20 minutes

    Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block

    At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed

  5. Number of participants with complete anesthesia of the arm at time 20 minutes

    Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block

    At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed

Secondary outcomes

  1. Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia at times 5, 10, 15, 20 minutes (except primary outcome) in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve

    Time frame: at times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  2. Number of patients with comfortable feeling, with unpleasant sensations and with pains during surgery, in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve (questionnaire completed by the anesthesist)

    Time frame: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  3. The total volume (mL) of local anesthetic used for the medial brachial cutaneous nerve block and the intercostobrachial nerve block

    Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  4. Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic

    Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  5. Number of participants (of the ultrasound-guided group) with : bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic

    Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  6. Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic.

    Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

The Effectiveness of Ultrasound-guided Technique Compared to Blind Technique in Medial Brachial Cutaneous Nerve Block and Intercostobrachial Nerve Block, in the Axilla

Acronym: ECHO_NCMB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Jul 28, 2017

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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