Analgesia, EpiduralNCT00981916
Ultrasound Determination of Needle Depth in Epidurals in Adult Patients
An observational study of Analgesia, Epidural and Surgery, run by University of Chicago at 1 site in United States.
Trial summary
The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Epidural, Surgery
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery
Who may be able to join
- The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery.
Who cannot join
- Parturients, prisoners and patients younger than 18 years old will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Determination of Needle Depth in Lumbar and Thoracic Epidurals in Adult Non-Parturient Patients
The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement.
The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.
- Conditions
- Analgesia, Epidural, Surgery
- Keywords
- determination of depth to epidural space using ultrasound
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound depth
Depth to epidural space as determined by ultrasound probe
Measured: At time of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981916
- Sponsor's protocol ID
- 16451A
- Status last verified
- Sep 2013
- First submitted
- 21 Sep 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Determination of Needle Depth in Lumbar and Thoracic Epidurals in Adult Non-Parturient Patients
- ClinicalTrials.gov ID
- NCT00981916
- Acronym / sponsor ID
- 16451A
- Conditions
- Analgesia, Epidural, Surgery
- Keywords
- determination of depth to epidural space using ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Sep 2009 (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 introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement.
The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery
Key inclusion criteria (1 listed)
- The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery.
Key exclusion criteria (1 listed)
- Parturients, prisoners and patients younger than 18 years old will be excluded from this 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
Ultrasound depth
Time frame: At time of exam
Depth to epidural space as determined by ultrasound probe
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 5 Sep 2013.
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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 Analgesia, Epidural and Surgery, run by University of Chicago 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 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 5 Sep 2013. 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 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?
Ultrasound depth (time frame: At time of exam). 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 5 Sep 2013.