Phrenic Nerve ParalysisBPBNCT03097159
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block
An observational study of Phrenic Nerve Paralysis, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Phrenic Nerve Paralysis
- What is being tested?
- Costoclavicular block
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 31 Mar 2018
- Phase
- Observational
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery of hand or forearm
Who may be able to join
- ASA I or II
- Scheduled for surgery of hand or forearm
Who cannot join
- Patient refusal
- Neuromuscular disease
- Pregnancy
- Previous history of surgery of periclavicular region
- Nerve injury history
- Bleeding tendency
- Allergy to local anesthetics
- Other contraindication of regional anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16377
About this study
The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.
Read the detailed description
Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.
Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.
In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.
- Conditions
- Phrenic Nerve Paralysis
- Being tested
- Costoclavicular block
- Keywords
- costoclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Costoclavicular blockProcedure or surgery
Group C for costoclavicular block Group S for supraclavicular block
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular block | For anesthesia, this group of patients will be received ultrasound guided costoclavicular block Receives: Procedure: Costoclavicular block | |
| Supraclavicular block | For anesthesia, this group of patients will be received ultrasound guided supraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm palsy
Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25~75% movement Normal : reduced less than 25%
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 May 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Why it stopped: Surgeon refuse the proposal, so we can's enroll the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic Nerve ParalysisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097159
- Sponsor's protocol ID
- 106421
- Acronym
- BPB
- Status last verified
- Jul 2018
- First submitted
- 26 Mar 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03097159
- Acronym / sponsor ID
- BPB / 106421
- Conditions
- Phrenic Nerve Paralysis
- Keywords
- costoclavicular block
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Surgeon refuse the proposal, so we can's enroll the patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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 investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.
Detailed description
Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.
Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.
In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular block | – | Procedure: Costoclavicular blockFor anesthesia, this group of patients will be received ultrasound guided costoclavicular block |
| Supraclavicular block | – | –For anesthesia, this group of patients will be received ultrasound guided supraclavicular block |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery of hand or forearm
Key inclusion criteria (2 listed)
- ASA I or II
- Scheduled for surgery of hand or forearm
Key exclusion criteria (8 listed)
- Patient refusal
- Neuromuscular disease
- Pregnancy
- Previous history of surgery of periclavicular region
- Nerve injury history
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 |
|---|---|---|
| Costoclavicular blockGroup C for costoclavicular block Group S for supraclavicular block | Procedure or surgery | Costoclavicular block |
Primary outcome
Diaphragm palsy
Time frame: 30 min
Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25~75% movement Normal : reduced less than 25%
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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.
In Kyong Yi, MD study director
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phrenic Nerve Paralysis, run by Ajou University School of Medicine at 1 site in South Korea.
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 8 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: withdrawn, as of the sponsor's last update on 3 Jul 2018. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Diaphragm palsy (time frame: 30 min). 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 3 Jul 2018.