Brachial Plexus InjuryNCT05810077
Feasibility of Brachial Plexus Ultrasound in Evaluation of Patients With Brachial Plexus Injuries
An observational study of Brachial Plexus Injury, run by Assiut University.
Trial summary
Evaluation of ultrasound as a diagnostic tool in assessment of patients with brachial plexus injuries before undergoing surgical exploration Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brachial Plexus Injury
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study sample calculated using Epi . as 36 patients.
Who may be able to join
- all patients ages with brachial plexus injuries
Who cannot join
- patients underwent brachial plexus surgery before
- patients with surgical emphysema
- patients with serious skeletal malformations
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of ultrasound as a diagnostic tool in assessment of patients with brachial plexus injuries before undergoing surgical exploration
Read the detailed description
Ultrasound of the brachial plexus is particularly good for assessing brachial plexus injuries, nerve sheath tumors,perineural fibrosis, metastasis, some inflammatory neuropathies, neuralgic amyotrophy and post traumatic sequele
- Conditions
- Brachial Plexus Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) .
Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) among all patients with brachial plexus injuries then compare our results with operative findings (as the gold standard ) to estimate sensitivity and specificity.
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mohamed Ahmed Lotfallah, Assiut University
- Investigators
- Hager M Ahmed, Master, Principal investigator, Assist universityNagham N Mahmood, Professor, Study chair, Assist university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810077
- Sponsor's protocol ID
- Brachial plexus ultrasound
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Brachial Plexus Ultrasound in Evaluation of Patients With Brachial Plexus Injuries
- ClinicalTrials.gov ID
- NCT05810077
- Acronym / sponsor ID
- Brachial plexus ultrasound
- Conditions
- Brachial Plexus Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
Evaluation of ultrasound as a diagnostic tool in assessment of patients with brachial plexus injuries before undergoing surgical exploration
Detailed description
Ultrasound of the brachial plexus is particularly good for assessing brachial plexus injuries, nerve sheath tumors,perineural fibrosis, metastasis, some inflammatory neuropathies, neuralgic amyotrophy and post traumatic sequele
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study sample calculated using Epi . as 36 patients.
Key inclusion criteria (1 listed)
- all patients ages with brachial plexus injuries
Key exclusion criteria (3 listed)
- patients underwent brachial plexus surgery before
- patients with surgical emphysema
- patients with serious skeletal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) .
Time frame: Within 2 weeks
Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) among all patients with brachial plexus injuries then compare our results with operative findings (as the gold standard ) to estimate sensitivity and specificity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Related trials for Brachial Plexus Injury
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Constraint Therapy for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
Obstetric Brachial Plexus Palsy
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.
Hager M Ahmed, Master principal investigator
Assist university
Nagham N Mahmood, Professor study chair
Assist university
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Hager mohamed Ahmed, Master (01093639662, doctorhagerlotfallah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive ultrasound findings of brachial plexus injuries ( nerve root avulsion, nerve rupture) . (time frame: Within 2 weeks). 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 28 Apr 2023.