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the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block

Primary Purpose

Injury of Upper Limb

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ropivacaine
ropivacaine mixed with dexmedetomidine
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury of Upper Limb focused on measuring dexmedetomidine, coracoid, brachial plexus block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status I or II;
  2. Aged 18-60 years;
  3. The elbow, forearm, wrist or hand surgery

Exclusion Criteria:

  1. History of allergy to local anesthetics;
  2. Coagulation dysfunction, neuromuscular disease or local infection;
  3. The operation time is longer than the local anesthetics effective time.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group Control

    Group Dexmedetomidine

    Arm Description

    40 ml 0.375% ropivacaine was injected after Locating brachial plexus.

    40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.

    Outcomes

    Primary Outcome Measures

    duration time
    effective analgesia time

    Secondary Outcome Measures

    onset time
    Visual analogue scale

    Full Information

    First Posted
    October 22, 2016
    Last Updated
    February 14, 2023
    Sponsor
    The First Hospital of Qinhuangdao
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02961361
    Brief Title
    the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
    Official Title
    the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 12, 2016 (Actual)
    Primary Completion Date
    March 30, 2017 (Actual)
    Study Completion Date
    May 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Hospital of Qinhuangdao

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through intravenous infusion，in order to improved the quality of block in regional anesthesia. In this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed with ropivacaine in coracoid approach brachial plexus block.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injury of Upper Limb
    Keywords
    dexmedetomidine, coracoid, brachial plexus block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Control
    Arm Type
    Experimental
    Arm Description
    40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
    Arm Title
    Group Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
    Intervention Type
    Drug
    Intervention Name(s)
    ropivacaine
    Intervention Description
    40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
    Intervention Type
    Drug
    Intervention Name(s)
    ropivacaine mixed with dexmedetomidine
    Intervention Description
    40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
    Primary Outcome Measure Information:
    Title
    duration time
    Description
    effective analgesia time
    Time Frame
    once per hour after surgery until 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    onset time
    Time Frame
    5,10,15,20,25,30 min after injection
    Title
    Visual analogue scale
    Time Frame
    2,6,12,24hour after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II; Aged 18-60 years; The elbow, forearm, wrist or hand surgery Exclusion Criteria: History of allergy to local anesthetics; Coagulation dysfunction, neuromuscular disease or local infection; The operation time is longer than the local anesthetics effective time.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    wensheng he, MD
    Organizational Affiliation
    Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30278495
    Citation
    He WS, Liu Z, Wu ZY, Sun HJ, Yang XC, Wang XL. The effect of dexmedetomidine in coracoid approach brachial plexus block under dual stimulation. Medicine (Baltimore). 2018 Sep;97(39):e12240. doi: 10.1097/MD.0000000000012240.
    Results Reference
    derived

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