Supraclavicular Brachial Plexus BlockNCT06352333
Parasagittal Vs Cornerpocket Approaches
A study testing supraclavicular ultrasound guided brachial plexus block in people with Supraclavicular Brachial Plexus Block, run by Sohag University at 1 site in Egypt.
Trial summary
Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery. Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraclavicular Brachial Plexus Block
- What is being tested?
- supraclavicular ultrasound guided brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2024to 1 Jan 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years old
- ASA grade I to II
- Elective upper limb surgery
Who cannot join
- Patient refusal.
- Patient with neurological deficit in the limb of surgery
- Patients with psychiatric disease.
- Coagulopathy.
- Morbid obesity.
- Known allergy to used local anathetics
- Local infection at the block site.
Trial locations and contacts
1 site in 1 country.
Wael A Mahmoud, assistant professor contact
About this study
Official title: Parasagittal Vs Cornerpocket Approaches for Ultrasound Guided Supraclavicular Brachial Plexus Block A Comparative Study
Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.
Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.
Read more
Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .
A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.
The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .
A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach
Read the detailed description
After approval of research ethics committee of Sohag University hospital, a written consent will be taken from all participants to use their data for research and educational purposes The study will be carried on 80 participants who undergo elective upper limb surgery for a comparative study.
In this study the investigators will use A 22 G Spinal needle , a high frequency linear probe of US and 2 % lidocaine and 0.5% bupivacaine as local anathetics ,Every participant will be informed about advantages and disadvantages of the research and has the right to withdraw at any stage without negative impact on medical service production.
For both types of block:
Wide bored cannula is inserted,Monitoring is applied (pulse,Ecg,Bp) Oxygen mask 5 liters , Participants were positioned supine with the head turned to the non-operative Side ( contralateral side), and a pillow under the head and shoulder with the ipsilateral arm placed adducted by the patient side.
After that we sterilize the skin and apply a local anesthetic (2-3 ml of2% lidocaine).
The total volume of the local anesthetic mixture was 30 ml (10 ml of 2% lidocaine mixed with 20 ml of 0.5% bupivacine ) Then participants will be divided randomly into 2 groups ,each group 40 participants.
- Conditions
- Supraclavicular Brachial Plexus Block
- Being tested
- supraclavicular ultrasound guided brachial plexus block
- Keywords
- brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraclavicular ultrasound guided brachial plexus blockProcedure or surgery
two approaches of ultrasound guided supraclavicular brachial plexus block in upper limb surgery : the cornerpocket supraclavicular brachial plexus block and parasagittal supraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Cornerpocket supraclavicular ultrasound guided brachial plexus block Receives: Procedure: supraclavicular ultrasound guided brachial plexus block |
| group B | Active comparator | Parasagital supraclavicular ultrasound guided brachial plexus block Receives: Procedure: supraclavicular ultrasound guided brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle visibility in both approaches
Measure the visibility of the needles in the ultrasound
Measured: 1 year
Secondary outcomes (1)
Duration of sensory and motor block
Measure the time of sensory and motor block start to happen after injecting local anathetics
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start2 Apr 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supraclavicular Brachial Plexus BlockStudies 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion criteria: * 18to60 yearsold * ASA grade I to II * Elective upper limb surgery
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Thabet Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352333
- Sponsor's protocol ID
- Parasagittal Vs Cornerpocket
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
PubMed 25376973Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
PubMed 17196502Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.
PubMed 14570677Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.
PubMed 19587618
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasagittal Vs Cornerpocket Approaches for Ultrasound Guided Supraclavicular Brachial Plexus Block A Comparative Study
- ClinicalTrials.gov ID
- NCT06352333
- Acronym / sponsor ID
- Parasagittal Vs Cornerpocket
- Conditions
- Supraclavicular Brachial Plexus Block
- Keywords
- brachial plexus block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Apr 2024 (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.
Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.
Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.
Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .
A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.
The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .
A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach
Detailed description
After approval of research ethics committee of Sohag University hospital, a written consent will be taken from all participants to use their data for research and educational purposes The study will be carried on 80 participants who undergo elective upper limb surgery for a comparative study.
In this study the investigators will use A 22 G Spinal needle , a high frequency linear probe of US and 2 % lidocaine and 0.5% bupivacaine as local anathetics ,Every participant will be informed about advantages and disadvantages of the research and has the right to withdraw at any stage without negative impact on medical service production.
For both types of block:
Wide bored cannula is inserted,Monitoring is applied (pulse,Ecg,Bp) Oxygen mask 5 liters , Participants were positioned supine with the head turned to the non-operative Side ( contralateral side), and a pillow under the head and shoulder with the ipsilateral arm placed adducted by the patient side.
After that we sterilize the skin and apply a local anesthetic (2-3 ml of2% lidocaine).
The total volume of the local anesthetic mixture was 30 ml (10 ml of 2% lidocaine mixed with 20 ml of 0.5% bupivacine ) Then participants will be divided randomly into 2 groups ,each group 40 participants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Inclusion criteria: * 18to60 yearsold * ASA grade I to II * Elective upper limb surgery
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: supraclavicular ultrasound guided brachial plexus blockCornerpocket supraclavicular ultrasound guided brachial plexus block |
| group B | Active comparator | Procedure: supraclavicular ultrasound guided brachial plexus blockParasagital supraclavicular ultrasound guided brachial plexus block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 60 years old
- ASA grade I to II
- Elective upper limb surgery
Key exclusion criteria (7 listed)
- Patient refusal.
- Patient with neurological deficit in the limb of surgery
- Patients with psychiatric disease.
- Coagulopathy.
- Morbid obesity.
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 |
|---|---|---|
| supraclavicular ultrasound guided brachial plexus blocktwo approaches of ultrasound guided supraclavicular brachial plexus block in upper limb surgery : the cornerpocket supraclavicular brachial plexus block and parasagittal supraclavicular brachial plexus block | Procedure or surgery | group A, group B |
Primary outcome
Needle visibility in both approaches
Time frame: 1 year
Measure the visibility of the needles in the ultrasound
1 secondary outcome
Duration of sensory and motor block
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 25376973Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
- Background: PubMed 17196502Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
- Background: PubMed 14570677Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.
- Background: PubMed 19587618Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.
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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.
Wael A Mahmoud, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraclavicular ultrasound guided brachial plexus block in people with Supraclavicular Brachial Plexus Block, run by Sohag University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada t Ahmed, resident (01069459544, nada_abdelrohman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle visibility in both approaches (time frame: 1 year). 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 NCT06352333, which also lists 4 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 8 Apr 2024.