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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928574
Other study ID # 2019CZTCWM1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date July 1, 2021

Study information

Verified date April 2019
Source Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound-Guided Plane Block
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
Conventional Block
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves

Locations

Country Name City State
China Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine Cangzhou Hebei

Sponsors (1)

Lead Sponsor Collaborator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with complete anesthesia 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 Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia 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 Volume of local anesthetic The volume (in milliliters) of 1% lidocaine used for the medial brachial cutaneous nerve and the intercostobrachial nerve block After nerve block immediately
Secondary Tourniquet tolerance 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
Secondary Good ultrasound view of theses nerves before and after the injection of the local anesthetic 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 Bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic 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 Bad ultrasound view of theses nerves before and after the injection of the local anesthetic 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
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