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USG Block of Cutaneous Nerves of the Arm

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ClinicalTrials.gov Identifier: NCT03928574
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Nerve Block Procedure: Ultrasound-Guided Plane Block Procedure: Conventional Block

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves:A Retrospective Observational Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Ultrasound-Guided
Ultrasound-Guided Plane Block
Procedure: Ultrasound-Guided Plane Block
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves

Conventional
Conventional Block
Procedure: Conventional Block
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
200
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928574


Contacts
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Contact: Ruizhao Lv, M.D +86-17772657375 lvruizhao@hotmail.com

Locations
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China, Hebei
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine Recruiting
Cangzhou, Hebei, China, 061001
Contact: Ruizhao Lv, M.D    +86-17772657375    lvruizhao@hotmail.com   
Sponsors and Collaborators
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Investigators
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Principal Investigator: Ruizha Lv, M.D Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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Responsible Party: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier: NCT03928574     History of Changes
Other Study ID Numbers: 2019CZTCWM1
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine:
Ultrasound-Guided Plane Block
Conventional Block