Upper Extremity Injury TraumaPhase 4NCT01334619
Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
A Phase 4 study testing appropriate volume of 0.5% ropivacaine in people with Upper Extremity Injury Trauma, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Extremity Injury Trauma
- What is being tested?
- appropriate volume of 0.5% ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to May 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elected upper extremity operations
- BMI 17~30kg/m2
- ASA I/II
Who cannot join
- Infection at injection site
- Sepsis
- Coagulation Dysfunction
- Phrenic nerve palsy
- Pneumothorax
- Recurrent laryngeal nerve palsy
- Clavicle fracture combined with nerve damage
Trial locations and contacts
1 site in 1 country.
About this study
The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.
Read the detailed description
Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.
- Conditions
- Upper Extremity Injury Trauma
- Being tested
- appropriate volume of 0.5% ropivacaine
- Keywords
- Anesthetic techniques,regional, Drug delivery,volume, Anesthetic, local: ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appropriate volume of 0.5% ropivacaineProcedure or surgery
Also called Naropin
initial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine volume titration | Other | Not described Receives: Procedure: appropriate volume of 0.5% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS of brachial plexus innervated area
effect and side effects of the present block approach for brachial plexus.
Measured: 20 minutes
Secondary outcomes (1)
medium effective ropivacaine volume
The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. EV95 was calculated using probit regression.
Measured: about 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity Injury TraumaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xiaoguang Zhang, MB, Principal investigator, Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334619
- Sponsor's protocol ID
- JSTMZ.2
- Status last verified
- Feb 2010
- First submitted
- 7 Apr 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT01334619
- Acronym / sponsor ID
- JSTMZ.2
- Conditions
- Upper Extremity Injury Trauma
- Keywords
- Anesthetic techniques,regional, Drug delivery,volume, Anesthetic, local: ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Apr 2011 (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.
The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.
Detailed description
Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ropivacaine volume titration | Other | Procedure: appropriate volume of 0.5% ropivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elected upper extremity operations
- BMI 17~30kg/m2
- ASA I/II
Key exclusion criteria (7 listed)
- Infection at injection site
- Sepsis
- Coagulation Dysfunction
- Phrenic nerve palsy
- Pneumothorax
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 |
|---|---|---|
| appropriate volume of 0.5% ropivacaineAlso: Naropininitial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed. | Procedure or surgery | ropivacaine volume titration |
Primary outcome
VAS of brachial plexus innervated area
Time frame: 20 minutes
effect and side effects of the present block approach for brachial plexus.
1 secondary outcome
medium effective ropivacaine volume
Time frame: about 2 months
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 13 Apr 2011.
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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.
Xiaoguang Zhang, MB principal investigator
Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China
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 appropriate volume of 0.5% ropivacaine in people with Upper Extremity Injury Trauma, run by Beijing Jishuitan Hospital 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 3 inclusion and 7 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 13 Apr 2011. 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?
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?
VAS of brachial plexus innervated area (time frame: 20 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 13 Apr 2011.