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

Upper Limb Surgery Clinical Trial

— ECHO_NCMB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940847
• Other study ID #: 2016-A01296-45
• Status: Completed
• Phase: N/A
• First received: October 16, 2016
• Last updated: July 27, 2017
• Start date: November 13, 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2017
• Est. primary completion date: January 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Upper Limb Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Chru Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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