NCT02961361

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

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

October 22, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 12, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

October 22, 2016

Last Update Submit

February 14, 2023

Conditions

Keywords

dexmedetomidinecoracoidbrachial plexus block

Outcome Measures

Primary Outcomes (1)

  • duration time

    effective analgesia time

    once per hour after surgery until 24 hours after surgery

Secondary Outcomes (2)

  • onset time

    5,10,15,20,25,30 min after injection

  • Visual analogue scale

    2,6,12,24hour after injection

Study Arms (2)

Group Control

EXPERIMENTAL

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

Drug: ropivacaine

Group Dexmedetomidine

EXPERIMENTAL

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

Drug: ropivacaine mixed with dexmedetomidine

Interventions

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

Group Control

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

Group Dexmedetomidine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arm Injuries

Interventions

RopivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • wensheng he, MD

    Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2016

First Posted

November 11, 2016

Study Start

November 12, 2016

Primary Completion

March 30, 2017

Study Completion

May 25, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02