Epidural Space DepthNCT02436109
Ultrasound Guidance for Epidural Analgesia and Anesthesia
An observational study of Epidural Space Depth, run by University of British Columbia at 1 site in Canada.
Trial summary
Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Space Depth
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to May 2016
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women
Who may be able to join
- term pregnancy
- elective cesarean
Who cannot join
- scoliosis
- high bmi
Trial locations and contacts
1 site in 1 country.
About this study
Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.
Read the detailed description
The investigators will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.
- Conditions
- Epidural Space Depth
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Parturients backs will be scanned using 3D ultrasound to measure the depth to the epidural space
| Study group | Role | What they receive |
|---|---|---|
| study group | elective cesarean delivery patients Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidural space depth
comparison of ultrasound measured epidural space to actual needle insertion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: study device broke
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Space DepthStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vit Gunka, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436109
- Sponsor's protocol ID
- H14-01152
- Status last verified
- Nov 2016
- First submitted
- 31 Mar 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance for Epidural Analgesia and Anesthesia
- ClinicalTrials.gov ID
- NCT02436109
- Acronym / sponsor ID
- H14-01152
- Conditions
- Epidural Space Depth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study device broke
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 May 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.
Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.
Detailed description
The investigators will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: Ultrasoundelective cesarean delivery patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (2 listed)
- term pregnancy
- elective cesarean
Key exclusion criteria (2 listed)
- scoliosis
- high bmi
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 |
|---|---|---|
| UltrasoundParturients backs will be scanned using 3D ultrasound to measure the depth to the epidural space | Device | study group |
Primary outcome
epidural space depth
Time frame: intraoperative
comparison of ultrasound measured epidural space to actual needle insertion
Results and safety
The study was stopped early (reason given: study device broke). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
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.
Vit Gunka, MD FRCPC principal investigator
University of British Columbia
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 Epidural Space Depth, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 2 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 17 Nov 2016. 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 Canada. 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: study device broke). 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?
epidural space depth (time frame: intraoperative). 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 17 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.