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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

Tracking Information
First Submitted Date May 8, 2018
First Posted Date April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 25, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title USG Block of Cutaneous Nerves of the Arm
Official Title Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves:A Retrospective Observational Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 200
Condition Nerve Block
Intervention
  • Procedure: Ultrasound-Guided Plane Block
    Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
  • Procedure: Conventional Block
    Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
Study Groups/Cohorts
  • Ultrasound-Guided
    Ultrasound-Guided Plane Block
    Intervention: Procedure: Ultrasound-Guided Plane Block
  • Conventional
    Conventional Block
    Intervention: Procedure: Conventional Block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ruizhao Lv, M.D +86-17772657375 lvruizhao@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928574
Other Study ID Numbers 2019CZTCWM1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Study Sponsor Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Ruizha Lv, M.D Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
PRS Account Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Verification Date April 2019