- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961361
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
February 14, 2023 updated by: The First Hospital of Qinhuangdao
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Control
40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
|
40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
|
Experimental: Group Dexmedetomidine
40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
|
40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration time
Time Frame: once per hour after surgery until 24 hours after surgery
|
effective analgesia time
|
once per hour after surgery until 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
onset time
Time Frame: 5,10,15,20,25,30 min after injection
|
5,10,15,20,25,30 min after injection
|
Visual analogue scale
Time Frame: 2,6,12,24hour after injection
|
2,6,12,24hour after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2016
Primary Completion (Actual)
March 30, 2017
Study Completion (Actual)
May 25, 2017
Study Registration Dates
First Submitted
October 22, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimate)
November 11, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Arm Injuries
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Ropivacaine
Other Study ID Numbers
- Dex
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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