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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

USG Block of Cutaneous Nerves of the Arm

Clinicaltrials.gov identifier NCT03928574

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted April 26, 2019

Study Description

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:Nerve Block
  • Intervention/Treatment: Procedure: Ultrasound-Guided Plane Block
    Procedure: Conventional Block
  • Phase: N/A
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 Design
  • 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 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: July 2021
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

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

Locations

China, Hebei
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou

Sponsors and Collaborators

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

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

More Information
  • 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
  • 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