USG Block of Cutaneous Nerves of the Arm

Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves:A Retrospective Observational Study

For superficial surgery of anteromedial and posteromedial surfaces of the upper arm, the medial brachial cutaneous nerve (MBCN) and the intercostobrachial nerve (ICBN) must be selectively blocked, in addition to an axillary brachial plexus block. We compared efficacy of ultrasound-guided (USG) versus conventional block of the MBCN and the ICBN.

Study Overview

Detailed Description

The primary objective of our study was to compare the effectiveness of conventional and USG blocks of the MBCN and the ICBN in the axillary fossa. Our hypothesis was that the proportion of patients with complete anesthesia in the entire posteromedial and anteromedial surface of the arm would be greater if a USG technique were used, compared with a conventional technique. The secondary objectives were onset time of complete anesthesia, volume of local anesthetic used for the procedure, tourniquet tolerance during surgery, and ultrasound visibility of MBCN and ICBN.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hebei
      • Cangzhou, Hebei, China, 061001
        • Recruiting
        • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refused to sign informed consent
  • Pregnant women
  • Allergic to the local anesthetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound-Guided
Ultrasound-Guided Plane Block
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
Conventional
Conventional Block
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete anesthesia
Time Frame: At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block
Number of participants with complete anesthesia of the arm in region innervated by the MBCN and the ICBN
At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia
Time Frame: At times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
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
Volume of local anesthetic
Time Frame: After nerve block immediately
The volume (in milliliters) of 1% lidocaine used for the medial brachial cutaneous nerve and the intercostobrachial nerve block
After nerve block immediately
Tourniquet tolerance
Time Frame: 3 hours 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
3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Good ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 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
Bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
Time Frame: 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
Bad ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ruizha Lv, M.D, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

April 25, 2019

First Posted (ACTUAL)

April 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2019CZTCWM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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