Clinical trial NCT02940847: Ultrasound-guided Versus Blind Technique in Medial Brachial Cutaneous Nerve and Intercostobrachial Nerve Blocks
Official title: The Effectiveness of Ultrasound-guided Technique Compared to Blind Technique in Medial Brachial Cutaneous Nerve Block and Intercostobrachial Nerve Block, in the Axilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Surgery
Keywords: ultrasound-guided technique
blind technique
medial brachial cutaneous nerve block
intercostobrachial nerve block
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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%

Primary outcomes:
measure: Number of participants with complete anesthesia in the lower half of the medial cutaneous area of the arm, at time 20 minutes
timeFrame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
measure: Number of participants with complete anesthesia in the upper half of the medial cutaneous area of the arm, at time 20 minutes
timeFrame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
measure: Number of participants with complete anesthesia in the lower half of the posterior cutaneous area of the arm, at time 20 minutes
timeFrame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
measure: Number of participants with complete anesthesia in the upper half of the posterior cutaneous area of the arm, at time 20 minutes
timeFrame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
measure: Number of participants with complete anesthesia of the arm at time 20 minutes
timeFrame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Secondary outcomes:
measure: 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
timeFrame: at times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
measure: 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)
timeFrame: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
measure: The total volume (mL) of local anesthetic used for the medial brachial cutaneous nerve block and the intercostobrachial nerve block
timeFrame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
measure: Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
timeFrame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
measure: 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
timeFrame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
measure: Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic.
timeFrame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: CHU NANCY
name: Hervé BOUAZIZ, Professor
role: STUDY_DIRECTOR
References:
citation: 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.