Upper Limb SurgeriesNCT05240729
Using Ultrasound in Infraclavicular in Upper Limb Surgeries
A study testing Infraclavicular brachial plexus block in people with Upper Limb Surgeries, run by Minia University at 1 site in Egypt.
Trial summary
Comparison of 3 approach of infraclavicular brachial plexus Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Limb Surgeries
- What is being tested?
- Infraclavicular brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2021to 24 Jun 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand
Who cannot join
- patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Retroclavicular Approach Versus Costoclavicular Approach of Infraclavicular Brachial Plexus Block for Upper Limb Surgeries
Comparison of 3 approach of infraclavicular brachial plexus
Read the detailed description
Comparison of retroclavicular \& costoclavicular and classic type of infraclavicular brachial plexus block for upper limb surgeries
- Conditions
- Upper Limb Surgeries
- Being tested
- Infraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular brachial plexus blockProcedure or surgery
Using ultrasound in 3different techniques of infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Retroclavicular | Active comparator | Retroclavicular approach to the infraclavicular region, the probe will be placed below and perpendicular to the clavicle, in a paramedian sagittal plane, medial to the coracoid process, to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will then be inserted in the supraclavicular fossa, approximately 1 cm posteriorly to the clavicle, and advanced in plane and strictly parallel to the ultrasound transducer. After passing the initial blind zone of about 2 cm caused by the acoustic shadow of the clavicle, the needle tip will be constantly seen, until it will be positioned posterior to the axillary artery. Receives: Procedure: Infraclavicular brachial plexus block |
| Costoclavicular | Active comparator | A new approach to the infraclavicular block The ultrasound transducer will be placed parallel and inferior to the clavicle and angled cephalad to optimize the ultrasound view. The block needle will be inserted in-plane from a lateral to medial direction into the costoclavicular space and the entire drug will be deposited in this location Receives: Procedure: Infraclavicular brachial plexus block |
| Classic | Active comparator | Infraclavicular brachial plexus block (ICPB) ultrasound probe will be placed near the lower edge of the clavicle, and a transverse view of the subclavian artery and vein will be visualized. Using a needle guide, the needle will be advanced under real-time ultrasound guidance, and local anaesthetic will be injected near the subclavian artery, 15 mm medially and 15 mm laterally to the artery. The extent of sensory and motor block will be evaluated at 30 minutes after the injection Receives: Procedure: Infraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor and sensory block success rate
Success rate 30 min after local anasthetic injections
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 posted15 Feb 2022
- Study start24 May 2021
- Primary completion24 Feb 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb SurgeriesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowayda Nabil gaber, Minia University
- Investigators
- Jozef zekry, MD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240729
- Sponsor's protocol ID
- 53:2021
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2022
- Last updated
- 10 Jan 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Retroclavicular Approach Versus Costoclavicular Approach of Infraclavicular Brachial Plexus Block for Upper Limb Surgeries
- ClinicalTrials.gov ID
- NCT05240729
- Acronym / sponsor ID
- 53:2021
- Conditions
- Upper Limb Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 15 Feb 2022 (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.
Comparison of 3 approach of infraclavicular brachial plexus
Detailed description
Comparison of retroclavicular \& costoclavicular and classic type of infraclavicular brachial plexus block for upper limb surgeries
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retroclavicular | Active comparator | Procedure: Infraclavicular brachial plexus blockRetroclavicular approach to the infraclavicular region, the probe will be placed below and perpendicular to the clavicle, in a paramedian sagittal plane, medial to the coracoid process, to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will then be inserted in the supraclavicular fossa, approximately 1 cm posteriorly to the clavicle, and advanced in plane and strictly parallel to the ultrasound transducer. After passing the initial blind zone of about 2 cm caused by the acoustic shadow of the clavicle, the needle tip will be constantly seen, until it will be positioned posterior to the axillary artery. |
| Costoclavicular | Active comparator | Procedure: Infraclavicular brachial plexus blockA new approach to the infraclavicular block The ultrasound transducer will be placed parallel and inferior to the clavicle and angled cephalad to optimize the ultrasound view. The block needle will be inserted in-plane from a lateral to medial direction into the costoclavicular space and the entire drug will be deposited in this location |
| Classic | Active comparator | Procedure: Infraclavicular brachial plexus blockInfraclavicular brachial plexus block (ICPB) ultrasound probe will be placed near the lower edge of the clavicle, and a transverse view of the subclavian artery and vein will be visualized. Using a needle guide, the needle will be advanced under real-time ultrasound guidance, and local anaesthetic will be injected near the subclavian artery, 15 mm medially and 15 mm laterally to the artery. The extent of sensory and motor block will be evaluated at 30 minutes after the injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand
Key exclusion criteria (1 listed)
- patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region
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 |
|---|---|---|
| Infraclavicular brachial plexus blockUsing ultrasound in 3different techniques of infraclavicular brachial plexus block | Procedure or surgery | Classic, Costoclavicular, Retroclavicular |
Primary outcome
Motor and sensory block success rate
Time frame: 30 min
Success rate 30 min after local anasthetic injections
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 10 Jan 2023.
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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.
Jozef zekry, MD study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular brachial plexus block in people with Upper Limb Surgeries, run by Minia 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 10 Jan 2023. 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?
Motor and sensory block success rate (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 10 Jan 2023.