Local Anesthetic Systemic ToxicityNCT01880034
Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments
An observational study of Local Anesthetic Systemic Toxicity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of potential barriers exist to routine lipid emulsion administration for those performing regional anesthesia including drug availability, drug… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Local Anesthetic Systemic Toxicity
- What is being tested?
- Lipid Emulsion Survey
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Regional Anesthesia Section heads at academic anesthesia institutions.
Who may be able to join
- Regional Anesthesia Section heads at academic anesthesia institutions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of potential barriers exist to routine lipid emulsion administration for those performing regional anesthesia including drug availability, drug cost and drug location. Inadequate training or lack of established protocols also have the potential to negatively impact patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability on obstetric units and found that it was nearly universally available.
The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact information for each anesthesia institution that engages in resident training. Investigators will contact these institutions by phone or email to obtain contact information for their regional anesthesia program director. In the absence of a program director, investigators will send a survey and consent information via email to the faculty physician most involved in regional anesthesia. Survey completion instructions (survey itself to be completed on Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the initial contact email. The study consent form will contain a description of the study itself. Survey participants will be allowed time to complete their survey in private at their discretion. Non-responders will receive two follow-up emails at one month intervals.
- Conditions
- Local Anesthetic Systemic Toxicity
- Being tested
- Lipid Emulsion Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid Emulsion SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| Regional Anesthesia Section Heads | This group will consist of Regional Anesthesia Section Heads at anesthesia residency training programs. Receives: Other: Lipid Emulsion Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is lipid emulsion available at all locations where regional anesthesia is practiced in your institution?
Survey options include
- Yes, lipid emulsion is available in the room where regional anesthesia is performed.
- Yes, lipid emulsion is available in a near-by pharmacy
- Yes, lipid emulsion is available in a central pharmacy
- No, lipid emulsion is not available in all locations where regional anesthesia is performed
Measured: Two months
Secondary outcomes (1)
If lipid emulsion is available to those practicing regional anesthesia at your institution, how long would it take to obtain it?
Possible responses include:
- Lipid emulsion is not available at our institution.
- Less than 10 minutes
- 10-30 minutes
- More than 30 minutes
Measured: Two Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthetic Systemic ToxicityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880034
- Sponsor's protocol ID
- 2013-0324
- Status last verified
- May 2017
- First submitted
- 13 Jun 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments
- ClinicalTrials.gov ID
- NCT01880034
- Acronym / sponsor ID
- 2013-0324
- Conditions
- Local Anesthetic Systemic Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jun 2013 (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.
Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of potential barriers exist to routine lipid emulsion administration for those performing regional anesthesia including drug availability, drug cost and drug location. Inadequate training or lack of established protocols also have the potential to negatively impact patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability on obstetric units and found that it was nearly universally available.
The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact information for each anesthesia institution that engages in resident training. Investigators will contact these institutions by phone or email to obtain contact information for their regional anesthesia program director. In the absence of a program director, investigators will send a survey and consent information via email to the faculty physician most involved in regional anesthesia. Survey completion instructions (survey itself to be completed on Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the initial contact email. The study consent form will contain a description of the study itself. Survey participants will be allowed time to complete their survey in private at their discretion. Non-responders will receive two follow-up emails at one month intervals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia Section Heads | – | Other: Lipid Emulsion SurveyThis group will consist of Regional Anesthesia Section Heads at anesthesia residency training programs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Regional Anesthesia Section heads at academic anesthesia institutions.
Key inclusion criteria (1 listed)
- Regional Anesthesia Section heads at academic anesthesia institutions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lipid Emulsion Survey | Other | Regional Anesthesia Section Heads |
Primary outcome
Is lipid emulsion available at all locations where regional anesthesia is practiced in your institution?
Time frame: Two months
Survey options include 1. Yes, lipid emulsion is available in the room where regional anesthesia is performed. 2. Yes, lipid emulsion is available in a near-by pharmacy 3. Yes, lipid emulsion is available in a central pharmacy 4. No, lipid emulsion is not available in all locations where regional anesthesia is performed
1 secondary outcome
If lipid emulsion is available to those practicing regional anesthesia at your institution, how long would it take to obtain it?
Time frame: Two Months.
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 12 May 2017.
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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 Local Anesthetic Systemic Toxicity, run by University of Wisconsin, Madison 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 0 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 12 May 2017. 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?
Is lipid emulsion available at all locations where regional anesthesia is practiced in your institution? (time frame: Two months). 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 12 May 2017.