Injury of Upper LimbPhase 4NCT02961361
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
A Phase 4 study testing ropivacaine and ropivacaine mixed with dexmedetomidine in people with Injury of Upper Limb, run by The First Hospital of Qinhuangdao.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Injury of Upper Limb
- What is being tested?
- ropivacaine and ropivacaine mixed with dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2016to 25 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II;
- Aged 18-60 years;
- The elbow, forearm, wrist or hand surgery
Who cannot join
- History of allergy to local anesthetics;
- Coagulation dysfunction, neuromuscular disease or local infection;
- The operation time is longer than the local anesthetics effective time.
About this study
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.
- Conditions
- Injury of Upper Limb
- Being tested
- ropivacaine, ropivacaine mixed with dexmedetomidine
- Keywords
- dexmedetomidine, coracoid, brachial plexus block
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
ropivacaine mixed with dexmedetomidineDrug
40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
| Study group | Role | What they receive |
|---|---|---|
| Group Control | Experimental | 40 ml 0.375% ropivacaine was injected after Locating brachial plexus. Receives: Drug: ropivacaine |
| Group Dexmedetomidine | Experimental | 40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus. Receives: Drug: ropivacaine mixed with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration time
effective analgesia time
Measured: once per hour after surgery until 24 hours after surgery
Secondary outcomes (2)
onset time
Measured: 5,10,15,20,25,30 min after injection
Visual analogue scale
Measured: 2,6,12,24hour after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start12 Nov 2016
- Primary completion30 Mar 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- wensheng he, MD, Principal investigator, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961361
- Sponsor's protocol ID
- Dex
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30278495
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02961361
- Acronym / sponsor ID
- Dex
- Conditions
- Injury of Upper Limb
- Keywords
- dexmedetomidine, coracoid, brachial plexus block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 12 Nov 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | Experimental | Drug: ropivacaine40 ml 0.375% ropivacaine was injected after Locating brachial plexus. |
| Group Dexmedetomidine | Experimental | Drug: ropivacaine mixed with dexmedetomidine40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I or II;
- Aged 18-60 years;
- The elbow, forearm, wrist or hand surgery
Key exclusion criteria (3 listed)
- History of allergy to local anesthetics;
- Coagulation dysfunction, neuromuscular disease or local infection;
- The operation time is longer than the local anesthetics effective time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine40 ml 0.375% ropivacaine was injected after Locating brachial plexus. | Drug | Group Control |
| ropivacaine mixed with dexmedetomidine40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus. | Drug | Group Dexmedetomidine |
Primary outcome
duration time
Time frame: once per hour after surgery until 24 hours after surgery
effective analgesia time
2 secondary outcomes
onset time
Time frame: 5,10,15,20,25,30 min after injection
Visual analogue scale
Time frame: 2,6,12,24hour after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 30278495He 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wensheng he, MD principal investigator
Hebei Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine and ropivacaine mixed with dexmedetomidine in people with Injury of Upper Limb, run by The First Hospital of Qinhuangdao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration time (time frame: once per hour after surgery until 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02961361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.