Brachial Plexus AnesthesiaNCT06475638
Brachial Artery Pulsatility Index in Supraclavicular Block
An observational study of Brachial Plexus Anesthesia and Diagnostic Accuracy, run by Cairo University at 1 site in Egypt.
Trial summary
Investigators aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brachial Plexus Anesthesia, Diagnostic Accuracy
- What is being tested?
- brachial artery doppler
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2024to 11 Jan 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient, ASA 1 and will receive supraclavicular brachial plexus block for forearm or hand surgery
Who may be able to join
- ASA 1 undergoing forearm or hand surgery
Who cannot join
- patient refusal allergy to local anesthetics fracture humerus Diabetes Melitus peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Brachial Artery Pulsatility Index as a Predictor of Successful Supraclavicular Block: a Prospective Observational Study
Investigators aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block
Read the detailed description
supraclavicular brachial plexus block gives adequate anesthesia and analgesia for arm and hand surgeries. successful block was classically evaluated via assessment of both sensory and motor functions, However this carry disadvantages of subjective assessment including patient cooperation. objective monitors of successful block depend on sympasthetic mediated changes including perfusion index, thermography, and LASER doppler.
However most of these tools depend on complicated technology and special devices.
therefore it was assumed that the use of brachial artery derived indices such as pulsatility index, resistive index, and waveform morphology would provide simple, easy and economic assessment tool for successful supraclavicular brachial plexus block
- Conditions
- Brachial Plexus Anesthesia, Diagnostic Accuracy
- Being tested
- brachial artery doppler
- Keywords
- pulsatility index, successful block, resistive index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachial artery dopplerDevice
brachial artery doppler evaluation before and after supraclavicular block
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in pulsatility index as a predictor to successful supraclavicular block
the difference between the index before and after the block divided by the index value before the block
Measured: baseline and at 5 minutes interval after block for 30 minutes
Secondary outcomes (2)
change in resistive index as a predictor for successful block
Measured: baseline then at 5 minutes interval for 30 minutes
change in waveform morphology as a predictor to successful block
Measured: baseline and within 10 minutes of block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Jul 2024
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475638
- Sponsor's protocol ID
- pulsatility index in SCB
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gamo K, Kuriyama K, Higuchi H, Uesugi A, Nakase T, Hamada M, Kawai H. Ultrasound-guided supraclavicular brachial plexus block in upper limb surgery: outcomes and patient satisfaction. Bone Joint J. 2014 Jun;96-B(6):795-9. doi: 10.1302/0301-620X.96B6.31893.
PubMed 24891581Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
PubMed 28854539Hollenbeck M, Hilbert N, Meusel F, Grabensee B. Increasing sensitivity and specificity of Doppler sonographic detection of renal transplant rejection with serial investigation technique. Clin Investig. 1994 Aug;72(8):609-15. doi: 10.1007/BF00227454.
PubMed 7819718Uysal AI, Altiparmak B, Korkmaz Toker M, Dinc Elibol F, Karalezli MN, Demirbilek S. Early and late blood flow changes in the brachial artery following brachial plexus block. Minerva Anestesiol. 2020 Sep;86(9):948-956. doi: 10.23736/S0375-9393.20.14309-8. Epub 2020 Jul 1.
PubMed 32613812Li J, Karmakar MK, Li X, Kwok WH, Ngan Kee WD. Regional hemodynamic changes after an axillary brachial plexus block: a pulsed-wave Doppler ultrasound study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):111-8. doi: 10.1097/AAP.0b013e318234007e.
PubMed 22030722Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.
PubMed 2970215
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brachial Artery Pulsatility Index as a Predictor of Successful Supraclavicular Block: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06475638
- Acronym / sponsor ID
- pulsatility index in SCB
- Conditions
- Brachial Plexus Anesthesia, Diagnostic Accuracy
- Keywords
- pulsatility index, successful block, resistive index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 26 Jun 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.
Investigators aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block
Detailed description
supraclavicular brachial plexus block gives adequate anesthesia and analgesia for arm and hand surgeries. successful block was classically evaluated via assessment of both sensory and motor functions, However this carry disadvantages of subjective assessment including patient cooperation. objective monitors of successful block depend on sympasthetic mediated changes including perfusion index, thermography, and LASER doppler.
However most of these tools depend on complicated technology and special devices.
therefore it was assumed that the use of brachial artery derived indices such as pulsatility index, resistive index, and waveform morphology would provide simple, easy and economic assessment tool for successful supraclavicular brachial plexus block
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient, ASA 1 and will receive supraclavicular brachial plexus block for forearm or hand surgery
Key inclusion criteria (1 listed)
- ASA 1 undergoing forearm or hand surgery
Key exclusion criteria (1 listed)
- patient refusal allergy to local anesthetics fracture humerus Diabetes Melitus peripheral vascular disease
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 artery dopplerbrachial artery doppler evaluation before and after supraclavicular block | Device | – |
Primary outcome
the change in pulsatility index as a predictor to successful supraclavicular block
Time frame: baseline and at 5 minutes interval after block for 30 minutes
the difference between the index before and after the block divided by the index value before the block
2 secondary outcomes
change in resistive index as a predictor for successful block
Time frame: baseline then at 5 minutes interval for 30 minutes
change in waveform morphology as a predictor to successful block
Time frame: baseline and within 10 minutes of block
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 Jan 2025.
- Results publication: PubMed 24891581Gamo K, Kuriyama K, Higuchi H, Uesugi A, Nakase T, Hamada M, Kawai H. Ultrasound-guided supraclavicular brachial plexus block in upper limb surgery: outcomes and patient satisfaction. Bone Joint J. 2014 Jun;96-B(6):795-9. doi: 10.1302/0301-620X.96B6.31893.
- Results publication: PubMed 28854539Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
- Results publication: PubMed 7819718Hollenbeck M, Hilbert N, Meusel F, Grabensee B. Increasing sensitivity and specificity of Doppler sonographic detection of renal transplant rejection with serial investigation technique. Clin Investig. 1994 Aug;72(8):609-15. doi: 10.1007/BF00227454.
- Results publication: PubMed 32613812Uysal AI, Altiparmak B, Korkmaz Toker M, Dinc Elibol F, Karalezli MN, Demirbilek S. Early and late blood flow changes in the brachial artery following brachial plexus block. Minerva Anestesiol. 2020 Sep;86(9):948-956. doi: 10.23736/S0375-9393.20.14309-8. Epub 2020 Jul 1.
- Results publication: PubMed 22030722Li J, Karmakar MK, Li X, Kwok WH, Ngan Kee WD. Regional hemodynamic changes after an axillary brachial plexus block: a pulsed-wave Doppler ultrasound study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):111-8. doi: 10.1097/AAP.0b013e318234007e.
- Results publication: PubMed 2970215Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Brachial Plexus Anesthesia and Diagnostic Accuracy, run by Cairo 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 1 inclusion and 1 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 Jan 2025. 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?
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?
the change in pulsatility index as a predictor to successful supraclavicular block (time frame: baseline and at 5 minutes interval after block for 30 minutes). 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 NCT06475638, which also lists 6 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 Jan 2025.