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

NCT ID: NCT02940847

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-13

Study Completion Date

2017-03-31

Brief Summary

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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

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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

Conditions

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Upper Limb Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé BOUAZIZ, Professor

Role: STUDY_DIRECTOR

CHU NANCY

Locations

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Chru Nancy

Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29905631 (View on PubMed)

Other Identifiers

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2016-A01296-45

Identifier Type: -

Identifier Source: org_study_id

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