Nerve BlockNCT01615952
Patient Positioning on Supraclavicular Nerve Block
An observational study of Nerve Block, run by Northwestern University at 1 site in United States.
Trial summary
Blockade of the brachial plexus using a supraclavicular approach provides excellent anesthesia for upper extremity surgery. The most serious complication specific to this block is pneumothorax. Subsequent modifications of this block including the use of ultrasound have lowered the risk from 6% to <1%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2014
- 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: Patients 18 y/o to 65 y/o, who are scheduled to receive a ultrasound-guided supraclavicular nerve block as part of their postoperative pain management.
Who may be able to join
- all patients, 18 y/o to 65 y/o, who are scheduled to receive an ultrasound- guided supraclavicular nerve block
Who cannot join
- patient refusal to be included in the study,
- the presence of language barrier that inhibits proper communication with the patient, contraindications to regional anesthesia (local infection, severe pulmonary disease, or preexisting neuropathy)
- history of allergy to amide local anesthetics or narcotics
- the presence of a progressive neurological deficit
- history of hepatorenal insufficiency
- the presence of a coagulopathy or infection
Show all 9Show fewer
- pregnancy
- a history of psychiatric disorder
- inability to follow study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feingberg School of Medicine
Chicago, Illinois, 60611
About this study
Blockade of the brachial plexus using a supraclavicular approach provides excellent anesthesia for upper extremity surgery. The most serious complication specific to this block is pneumothorax. Subsequent modifications of this block including the use of ultrasound have lowered the risk from 6% to <1%. Case reports remain and authors have described certain factors and strategies to reduce this risk. Most texts and journals describe the patient in a supine or semi-sitting position during the block. At the investigators institution the investigators perform the block in a semi-sitting position to facilitate needle tip visibility with ultrasound. The investigators plan to obtain ultrasound anatomic measurements in three different positions (supine, semi-sitting, sitting) using patients consented for supraclavicular nerve blocks.
- Conditions
- Nerve Block
- Keywords
- Supraclavicular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sitting Position (head of bed 90 degrees) | Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" | |
| Semi-sitting position (45 degrees) | Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" | |
| Supine position | Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient positioning
Ultrasound measurements will be made at three different positions: Sitting, semi-sitting, and supine. The ultrasound measurements include A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket"
Measured: Postoperative Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoun Nader, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615952
- Sponsor's protocol ID
- STU00058413
- Other IDs
- Northwestern University
- Status last verified
- Mar 2015
- First submitted
- 7 Jun 2012
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Positioning on Supraclavicular Nerve Block
- ClinicalTrials.gov ID
- NCT01615952
- Acronym / sponsor ID
- STU00058413
- Conditions
- Nerve Block
- Keywords
- Supraclavicular Block
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jun 2012 (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.
Blockade of the brachial plexus using a supraclavicular approach provides excellent anesthesia for upper extremity surgery. The most serious complication specific to this block is pneumothorax. Subsequent modifications of this block including the use of ultrasound have lowered the risk from 6% to <1%. Case reports remain and authors have described certain factors and strategies to reduce this risk. Most texts and journals describe the patient in a supine or semi-sitting position during the block. At the investigators institution the investigators perform the block in a semi-sitting position to facilitate needle tip visibility with ultrasound. The investigators plan to obtain ultrasound anatomic measurements in three different positions (supine, semi-sitting, sitting) using patients consented for supraclavicular nerve blocks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting Position (head of bed 90 degrees) | – | –Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" |
| Semi-sitting position (45 degrees) | – | –Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" |
| Supine position | – | –Ultrasound measurements will be performed. A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 y/o to 65 y/o, who are scheduled to receive a ultrasound-guided supraclavicular nerve block as part of their postoperative pain management.
Key inclusion criteria (1 listed)
- all patients, 18 y/o to 65 y/o, who are scheduled to receive an ultrasound- guided supraclavicular nerve block
Key exclusion criteria (9 listed)
- patient refusal to be included in the study,
- the presence of language barrier that inhibits proper communication with the patient, contraindications to regional anesthesia (local infection, severe pulmonary disease, or preexisting neuropathy)
- history of allergy to amide local anesthetics or narcotics
- the presence of a progressive neurological deficit
- history of hepatorenal insufficiency
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
patient positioning
Time frame: Postoperative Day One
Ultrasound measurements will be made at three different positions: Sitting, semi-sitting, and supine. The ultrasound measurements include A= skin to the pleura at the level lateral to the subclavian artery, B= skin to center of the subclavian artery, C= skin to first rib, D= skin to "corner pocket"
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
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 Nerve Block, run by Northwestern University at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 30 Mar 2015. 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 United States. 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 was stopped early (reason given: Lack of recruitment). 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?
patient positioning (time frame: Postoperative Day One). 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 30 Mar 2015.