NCT03928574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

May 8, 2018

Last Update Submit

April 8, 2024

Conditions

Keywords

Ultrasound-Guided Plane BlockConventional Block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia

    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

    After nerve block immediately

  • Tourniquet tolerance

    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

    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

    5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

  • +1 more secondary outcomes

Study Arms (2)

Ultrasound-Guided

Ultrasound-Guided Plane Block

Procedure: Ultrasound-Guided Plane Block

Conventional

Conventional Block

Procedure: Conventional Block

Interventions

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

Ultrasound-Guided

Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves

Conventional

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, 061001, China

Location

Study Officials

  • Ruizha Lv, M.D

    Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

April 26, 2019

Study Start

April 1, 2019

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

April 9, 2024

Record last verified: 2019-04

Locations