Hand Injuries and DisordersNCT04215614
Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
A study testing Lidocaine and Bupivacaine solution, Costoclavicular block and Lateral Sagittal block in people with Hand Injuries and Disorders and Forearm Injuries, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Hand Injuries and Disorders, Forearm Injuries
- What is being tested?
- Lidocaine and Bupivacaine solution, Costoclavicular block and Lateral Sagittal block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 10 Apr 2020
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-II patients
- Patients who will undergo hand or forearm surgery
Who cannot join
- Infection in the area to be injected
- Coagulopathy,
- Previously known neurological damage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.
- Conditions
- Hand Injuries and Disorders, Forearm Injuries
- Being tested
- Lidocaine and Bupivacaine solution, Costoclavicular block, Lateral Sagittal block
- Medical subject headings
- Hand Injuries, Disease, Forearm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine and Bupivacaine solutionDrug
1:1 ratio 2% lidocaine, and 0.5% bupivacaine
Costoclavicular blockDevice
Ultrasound-guided costoclavicular brachial plexus block
Lateral Sagittal blockDevice
Ultrasound-guided lateral sagittal brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Group Lateral Sagittal | Active comparator | Ultrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine Receives: Drug: Lidocaine and Bupivacaine solution; Device: Lateral Sagittal block |
| Group Costoclavicular | Active comparator | Ultrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine Receives: Drug: Lidocaine and Bupivacaine solution; Device: Costoclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block performance time
The time interval between the contact of the ultrasound probe to skin and end of local anesthetics injection.
Measured: Twenty minutes before surgery
Secondary outcomes (1)
Visual analog pain score
Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 Jan 2020
- Primary completion3 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215614
- Sponsor's protocol ID
- LS vs Costo BPB Pediatric
- Status last verified
- Apr 2020
- First submitted
- 29 Dec 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yayik AM, Cesur S, Ozturk F, Celik EC, Ahiskalioglu A. Ultrasound guided costoclavicular approach to brachial plexus: First pediatric report. J Clin Anesth. 2019 Aug;55:136-137. doi: 10.1016/j.jclinane.2019.01.008. Epub 2019 Jan 15. No abstract available.
PubMed 30658327Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
PubMed 29923950Yayik AM, Cesur S, Ozturk F, Celik EC, Naldan ME, Ahiskalioglu A. Comparison of the lateral sagittal and costoclavicular approaches for ultrasound-guided infraclavicular block in pediatric patients: a prospective randomized study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744178. doi: 10.1016/j.bjane.2021.05.005. Epub 2021 Jun 6.
PubMed 34090921
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
- ClinicalTrials.gov ID
- NCT04215614
- Acronym / sponsor ID
- LS vs Costo BPB Pediatric
- Conditions
- Hand Injuries and Disorders, Forearm Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 2 Jan 2020 (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.
Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Lateral Sagittal | Active comparator | Drug: Lidocaine and Bupivacaine solution, Device: Lateral Sagittal blockUltrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine |
| Group Costoclavicular | Active comparator | Drug: Lidocaine and Bupivacaine solution, Device: Costoclavicular blockUltrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist's physiologic state I-II patients
- Patients who will undergo hand or forearm surgery
Key exclusion criteria (3 listed)
- Infection in the area to be injected
- Coagulopathy,
- Previously known neurological damage
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 |
|---|---|---|
| Lidocaine and Bupivacaine solution1:1 ratio 2% lidocaine, and 0.5% bupivacaine | Drug | Group Costoclavicular, Group Lateral Sagittal |
| Costoclavicular blockUltrasound-guided costoclavicular brachial plexus block | Device | Group Costoclavicular |
| Lateral Sagittal blockUltrasound-guided lateral sagittal brachial plexus block | Device | Group Lateral Sagittal |
Primary outcome
Block performance time
Time frame: Twenty minutes before surgery
The time interval between the contact of the ultrasound probe to skin and end of local anesthetics injection.
1 secondary outcome
Visual analog pain score
Time frame: Postoperative 24 hours
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 14 Apr 2020.
- Background: PubMed 30658327Yayik AM, Cesur S, Ozturk F, Celik EC, Ahiskalioglu A. Ultrasound guided costoclavicular approach to brachial plexus: First pediatric report. J Clin Anesth. 2019 Aug;55:136-137. doi: 10.1016/j.jclinane.2019.01.008. Epub 2019 Jan 15. No abstract available.
- Background: PubMed 29923950Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
- Derived from this study: PubMed 34090921Yayik AM, Cesur S, Ozturk F, Celik EC, Naldan ME, Ahiskalioglu A. Comparison of the lateral sagittal and costoclavicular approaches for ultrasound-guided infraclavicular block in pediatric patients: a prospective randomized study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744178. doi: 10.1016/j.bjane.2021.05.005. Epub 2021 Jun 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Bupivacaine solution, Costoclavicular block and Lateral Sagittal block in people with Hand Injuries and Disorders and Forearm Injuries, run by Ataturk University at 1 site in Turkey (Türkiye).
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 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 14 Apr 2020. 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 Turkey (Türkiye). 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?
Block performance time (time frame: Twenty minutes before 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 NCT04215614, which also lists 3 linked publications.
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 14 Apr 2020.