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

NCT02940847 | Completed

• 1 other identifier: 2016-A01296-45
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Surgery

Keywords

ultrasound-guided technique; blind technique; medial brachial cutaneous nerve block; intercostobrachial nerve block

Outcome Measures

Primary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary Outcomes (6)

• 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

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

• 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)

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

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

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

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

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

• 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

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

Study Arms (2)

blind technique

ACTIVE COMPARATOR

Investigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. The blind technique consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.

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

ultrasound-guided technique

ACTIVE COMPARATOR

Investigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. In the ultrasound-guided technique, ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.

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

Interventions

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.

blind technique

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.

ultrasound-guided technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy

Nancy, 54035, France

Location

Related Publications (1)

• Magazzeni P, Jochum D, Iohom G, Mekler G, Albuisson E, Bouaziz H. Ultrasound-Guided Selective Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves: A Randomized Clinical Trial. Reg Anesth Pain Med. 2018 Nov;43(8):832-837. doi: 10.1097/AAP.0000000000000823.

  PMID: 29905631 DERIVED

Study Officials

• Hervé BOUAZIZ, Professor

  CHU NANCY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 21, 2016
• Study Start: November 13, 2016
• Primary Completion: January 26, 2017
• Study Completion: March 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)