the Study Focuses on Comparing Between Supraclavicular and Axillary BlocksNCT03377985
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
A study testing brachial plexus block in people with the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks, run by Ain Shams University.
Trial summary
The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks
- What is being tested?
- 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
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2016
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery
Who cannot join
- Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway disease
About this study
Official title: Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients: A Comparative Study
The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively. The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.
- Being tested
- brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachial plexus blockProcedure or surgery
Also called nerve block
| Study group | Role | What they receive |
|---|---|---|
| axillary brachial plexus block group | Active comparator | Patients placed in the supine position with arm to be blocked abducted and externally rotated. After sterilization of the axilla ultrasound device with high frequency of 8-12 MHZ, linear transducer was put parallel to the anterior axillary fold at axilla to identify the axillary artery, lateral, medial and posterior cords of the brachial plexus in relation to the axillary artery. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe, 7-10 ml of bupivacaine 0.5% was injected around each cord of the brachial plexus Receives: Procedure: brachial plexus block |
| supraclavicular brachial plexus block group | Active comparator | patients placed in the supine position with the head of the bed elevated 30 degrees and patient's head turned away from the side to be blocked after skin disinfection, ultrasound device was put transversely parallel to and above the middle third of the clavicle, the probe was tilted till identification of the subclavian artery, 1st rib, pleura and brachial plexus lateral to the subclavian artery and above the 1st rib. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the lateral side of the probe. A needle was inserted in plane 1 cm lateral to the probe when adjacent to brachial plexus 25 ml of bubivacaine 0.5% was injected around the brachial plexus Receives: Procedure: brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
block related complications
failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax
Measured: 24 hours after the block
Secondary outcomes (1)
number of first needle pass
how many times the needle is inserted till we can inject local anesthesia in a proper site
Measured: 10-20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Study Focuses on Comparing Between Supraclavicular and Axillary BlocksStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377985
- Sponsor's protocol ID
- FWA 000017585
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients: A Comparative Study
- ClinicalTrials.gov ID
- NCT03377985
- Acronym / sponsor ID
- FWA 000017585
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 19 Dec 2017 (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.
The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively. The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| axillary brachial plexus block group | Active comparator | Procedure: brachial plexus blockPatients placed in the supine position with arm to be blocked abducted and externally rotated. After sterilization of the axilla ultrasound device with high frequency of 8-12 MHZ, linear transducer was put parallel to the anterior axillary fold at axilla to identify the axillary artery, lateral, medial and posterior cords of the brachial plexus in relation to the axillary artery. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe, 7-10 ml of bupivacaine 0.5% was injected around each cord of the brachial plexus |
| supraclavicular brachial plexus block group | Active comparator | Procedure: brachial plexus blockpatients placed in the supine position with the head of the bed elevated 30 degrees and patient's head turned away from the side to be blocked after skin disinfection, ultrasound device was put transversely parallel to and above the middle third of the clavicle, the probe was tilted till identification of the subclavian artery, 1st rib, pleura and brachial plexus lateral to the subclavian artery and above the 1st rib. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the lateral side of the probe. A needle was inserted in plane 1 cm lateral to the probe when adjacent to brachial plexus 25 ml of bubivacaine 0.5% was injected around the brachial plexus |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery
Key exclusion criteria (1 listed)
- Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway 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 plexus blockAlso: nerve block | Procedure or surgery | axillary brachial plexus block group, supraclavicular brachial plexus block group |
Primary outcome
block related complications
Time frame: 24 hours after the block
failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax
1 secondary outcome
number of first needle pass
Time frame: 10-20 min
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 19 Dec 2017.
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.
Questions about this trial
What is this clinical trial studying?
A study testing brachial plexus block in people with the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks, run by Ain Shams 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 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 19 Dec 2017. 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?
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 related complications (time frame: 24 hours after the block). 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 19 Dec 2017.