Regional AnesthesiaNCT02383134
Maximal Distance for Successful Supraclavicular Block
An observational study of Regional Anesthesia and Ultrasound, run by Tunisian Military Hospital.
Trial summary
The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Regional Anesthesia, Ultrasound, Supraclavicular Block
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing upper limb surgery surgery (hand, forearm, elbow)
Who may be able to join
- ASA physical status I-III
- 18-85 years of age, inclusive
- surgery less than 3 hours
Who cannot join
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit in the area to be blocked
- pregnancy
- history of neck surgery or radiotherapy
- inability to understand the informed consent and demands of the study
About this study
Official title: The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block
The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.
The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.
This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.
- Conditions
- Regional Anesthesia, Ultrasound, Supraclavicular Block
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve
Measured: 30 minutes
Secondary outcomes (3)
•The onset time of sensory and motor block
Measured: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
The proportion of inadequate and failed blocks.
Measured: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
The presence of other complications such as hematoma, infection, pneumothorax.
Measured: up to 48 hours post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunisian Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr trabelsi walid, Tunisian Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383134
- Sponsor's protocol ID
- TunisianMH
- Status last verified
- Mar 2015
- First submitted
- 27 Feb 2015
- Last updated
- 13 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02383134
- Acronym / sponsor ID
- TunisianMH
- Conditions
- Regional Anesthesia, Ultrasound, Supraclavicular Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tunisian Military HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- 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 achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.
The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.
This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing upper limb surgery surgery (hand, forearm, elbow)
Key inclusion criteria (3 listed)
- ASA physical status I-III
- 18-85 years of age, inclusive
- surgery less than 3 hours
Key exclusion criteria (5 listed)
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit in the area to be blocked
- pregnancy
- history of neck surgery or radiotherapy
- inability to understand the informed consent and demands of the study
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
Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve
Time frame: 30 minutes
3 secondary outcomes
•The onset time of sensory and motor block
Time frame: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
The proportion of inadequate and failed blocks.
Time frame: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
The presence of other complications such as hematoma, infection, pneumothorax.
Time frame: up to 48 hours post operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and Ultrasound, run by Tunisian Military Hospital.
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 5 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 13 May 2015. 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?
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?
Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve (time frame: 30 minutes). 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 13 May 2015.