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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Surgery
• Intervention / Treatment: Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique; Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54035
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: blind technique; 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; It consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.
Active Comparator: ultrasound-guided technique; 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; Ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of participants (of the ultrasound-guided group) with bad 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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Hervé BOUAZIZ, Professor, CHU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2016
• Primary Completion (Actual): January 26, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 16, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound-guided technique; blind technique; medial brachial cutaneous nerve block; intercostobrachial nerve block
• Other Study ID Numbers: 2016-A01296-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No