AnesthesiaPhase 4NCT02323282
The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block
A Phase 4 study testing ropivacaine in people with Anesthesia, run by Yu Shan at 1 site in China.
Trial summary
To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2014
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I or II
Who cannot join
- upper limb paresthesia
- allergic to local anesthetics
- surgery history of clavicle
- BMI>30kg/m^2
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology,Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Shan Yu, graduate, +86-18930173658, shanyu800302@126.com
About this study
To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.
- Conditions
- Anesthesia
- Being tested
- ropivacaine
- Keywords
- Dose-response relationship, Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| ropivacine | Other | Not described Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the affection of nerve block
The anesthetic efficacy of five nerves, respectively named lateral antebrachial cutaneous nerve, medial cutaneous nerve of the forearm, radial nerve, median nerve, and ulnar nerve was assessed within 30 min after anesthesia. The next concentration of ropivacaine was adjusted according to the response of the previous patient using up-down sequential allocation.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Shan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Shan, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323282
- Sponsor's protocol ID
- Yu Shan
- Status last verified
- Oct 2014
- First submitted
- 5 Oct 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02323282
- Acronym / sponsor ID
- Yu Shan
- Conditions
- Anesthesia
- Keywords
- Dose-response relationship, Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yu ShanUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Dec 2014 (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.
To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ropivacine | Other | Drug: ropivacaine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I or II
Key exclusion criteria (4 listed)
- upper limb paresthesia
- allergic to local anesthetics
- surgery history of clavicle
- BMI>30kg/m^2
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 |
|---|---|---|
| ropivacaine | Drug | ropivacine |
Primary outcome
the affection of nerve block
Time frame: 30 minutes
The anesthetic efficacy of five nerves, respectively named lateral antebrachial cutaneous nerve, medial cutaneous nerve of the forearm, radial nerve, median nerve, and ulnar nerve was assessed within 30 min after anesthesia. The next concentration of ropivacaine was adjusted according to the response of the previous patient using up-down sequential allocation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine in people with Anesthesia, run by Yu Shan at 1 site in China.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan Yu (86-18930173658, shanyu800302@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the affection of nerve block (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2014.