Upper ExtremityRIBPANCT01075503
Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade
A study testing brachial plexus block in people with Upper Extremity, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
Brachial plexus block is a frequently used technique for upper extremity surgery. All present approaches and techniques have certain advantages and disadvantages. It's necessary to develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is easy to perform, 3) isn't restricted by… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Extremity
- What is being tested?
- brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Jan 2010
- Phase
- Interventional
- 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
- ASA physical status Ⅰ~Ⅱ
- Scheduled for elective upper extremity surgery
Who cannot join
- Age <18 yr or >60 yr
- Body weight <50kg or >100kg
- Serious brain, heart, lung, liver, kidney diseases or diabetes mellitus
- Incapability or refusing to be enrolled
- Infection at the site of puncture, skin ulcer
- Coagulopathy
- Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approach for Brachial Plexus Block: Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade
Brachial plexus block is a frequently used technique for upper extremity surgery. All present approaches and techniques have certain advantages and disadvantages. It's necessary to develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution, 5) causes as few complications as possible, 6) easily place a secured catheter for post-operative analgesia. The investigators established the retrograde infraclavicular brachial plexus block approach. The investigators compared and verified the feasibility, efficacy and safety of this new approach with other classic approaches to brachial plexus block.
Read the detailed description
Traditional brachial plexus block approaches have certain limitations. This study evaluated the effectiveness, safety and feasibility of a new retrograde infraclavicular brachial plexus block as compared with interscalene and supraclavicular approaches. 90 patients scheduled for elective upper limb surgery were recruited and randomized into three groups, 30 for each group. Patients of Group A received retrograde infraclavicular block, interscalene (by Winnie) approach for Group B and supraclavicular (by Kulenkampff) approach for Group C. The retrograde infraclavicular block was performed with the insertion point medial to the coracoid process and the needle advanced to ipsilateral interscalene groove. Neurostimulation was used and 40ml of 0.5% ropivacaine were injected. Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30min after local anesthetic injection. The needle insertion depth, angles in coronary and sagittal planes of Group A were also recorded. Success rate of each nerve sensory block, sensory block result, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects are all compared among groups.
- Conditions
- Upper Extremity
- Being tested
- brachial plexus block
- Keywords
- Supraclavicular, Interscalene, Infraclavicular, Brachial plexus block, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachial plexus blockProcedure or surgery
Also called NAROPIN® 1.0%
0.5% Ropivacaine 40ml
| Study group | Role | What they receive |
|---|---|---|
| retrograde infraclavicular | Experimental | Patients were received retrograde infraclavicular brachial plexus block. Receives: Procedure: brachial plexus block |
| interscalene | Active comparator | Patients were received interscalene brachial plexus block. Receives: Procedure: brachial plexus block |
| supraclavicular | Active comparator | Patients were received supraclavicular brachial plexus block. Receives: Procedure: brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of nerve sensory block
Measured: 30 minutes
Secondary outcomes (1)
Success rate of motor block
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 posted25 Feb 2010 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper ExtremityStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 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, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075503
- Sponsor's protocol ID
- JSTMZ.1
- Acronym
- RIBPA
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approach for Brachial Plexus Block: Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade
- ClinicalTrials.gov ID
- NCT01075503
- Acronym / sponsor ID
- RIBPA / JSTMZ.1
- Conditions
- Upper Extremity
- Keywords
- Supraclavicular, Interscalene, Infraclavicular, Brachial plexus block, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Feb 2010 (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.
Brachial plexus block is a frequently used technique for upper extremity surgery. All present approaches and techniques have certain advantages and disadvantages. It's necessary to develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution, 5) causes as few complications as possible, 6) easily place a secured catheter for post-operative analgesia. The investigators established the retrograde infraclavicular brachial plexus block approach. The investigators compared and verified the feasibility, efficacy and safety of this new approach with other classic approaches to brachial plexus block.
Detailed description
Traditional brachial plexus block approaches have certain limitations. This study evaluated the effectiveness, safety and feasibility of a new retrograde infraclavicular brachial plexus block as compared with interscalene and supraclavicular approaches. 90 patients scheduled for elective upper limb surgery were recruited and randomized into three groups, 30 for each group. Patients of Group A received retrograde infraclavicular block, interscalene (by Winnie) approach for Group B and supraclavicular (by Kulenkampff) approach for Group C. The retrograde infraclavicular block was performed with the insertion point medial to the coracoid process and the needle advanced to ipsilateral interscalene groove. Neurostimulation was used and 40ml of 0.5% ropivacaine were injected. Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30min after local anesthetic injection. The needle insertion depth, angles in coronary and sagittal planes of Group A were also recorded. Success rate of each nerve sensory block, sensory block result, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects are all compared among groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| retrograde infraclavicular | Experimental | Procedure: brachial plexus blockPatients were received retrograde infraclavicular brachial plexus block. |
| interscalene | Active comparator | Procedure: brachial plexus blockPatients were received interscalene brachial plexus block. |
| supraclavicular | Active comparator | Procedure: brachial plexus blockPatients were received supraclavicular brachial plexus block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status Ⅰ~Ⅱ
- Scheduled for elective upper extremity surgery
Key exclusion criteria (7 listed)
- Age <18 yr or >60 yr
- Body weight <50kg or >100kg
- Serious brain, heart, lung, liver, kidney diseases or diabetes mellitus
- Incapability or refusing to be enrolled
- Infection at the site of puncture, skin ulcer
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 |
|---|---|---|
| brachial plexus blockAlso: NAROPIN® 1.0%0.5% Ropivacaine 40ml | Procedure or surgery | interscalene, retrograde infraclavicular, supraclavicular |
Primary outcome
Success rate of nerve sensory block
Time frame: 30 minutes
1 secondary outcome
Success rate of motor block
Time frame: 30 minutes
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 25 Feb 2010.
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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, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brachial plexus block in people with Upper Extremity, 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 2 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 25 Feb 2010. 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.
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?
Success rate of nerve sensory 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 25 Feb 2010.