PregnancyNCT01192074
Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
An observational study of Pregnancy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2012
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients in labor Pregnant patients scheduled for cesarean section
Who may be able to join
- Pregnant women in labor or scheduled for induction requesting labor epidural analgesia
- Pregnant women scheduled for cesarean delivery
- Pregnant women in labor who are going to have a non-emergent cesarean delivery under spinal anesthesia
Who cannot join
- Emergency delivery
- Emergency cesarean section
- Advanced labor
- Contraindications to neuraxial analgesia/anesthesia
- Unable to understand consent
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Women's and Children's Hospital
Columbia, Missouri, 65201
About this study
This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.
Read the detailed description
All patients presenting in labor or are having a cesarean delivery are eligible except: patients who are under age 18, have contraindications to regional anesthesia, in advanced labor, having emergency conditions and/or unable to understand the consent process.
- Data collected include:
- Ultrasound depth in transverse and oblique sagittal views
- Actual needle depth
- Level of placement
- Number of separate needle placements
- Number of needle redirects
- Angle of probe
- Angle of needle
- Total number of attempts
- Pt height
- Pt weight
- Pt BMI
- Pt age
- Pt gravity/parity
- Pt co-morbidities, e.g. pre-eclampsia
- Procedure performed
- Operator (Attending, CA-1, CA-2, CA-3, CRNA)
What is currently being examined is the correlation between ultrasound depth of the target area vs actual needle depth
- Conditions
- Pregnancy
- Being tested
- Ultrasound
- Keywords
- Obstetric, Analgesia, Anesthesia, Obstetric Anesthesia, Obstetric Analgesia, ultrasound, ultrasonography, epidural analgesia, epidural anesthesia, spinal anesthesia, neuraxial anesthesia, neuraxial analgesia, pregnancy, labor, cesarean delivery, cesarean section
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Preprocedure ultrasound examination of the spine
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound of the spine | Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Ultrasound vs Needle Depth
The ultrasound measured depth taken via oblique sagittal views and transverse views of the epidural space for epidural analgesia or intrathecal space for spinal anesthesia will be correlated with actual needle depth
Measured: Beginning of ultrasound exam to end of ultrasound exam: average 5 min
Secondary outcomes (1)
Attempt Number
The number of needle placement attemtps: an attempt is defined as a separate needle placement The number of needle redirects: a redirect is defined at the need for changing the angle of needle direction at each separate needle attempt
Measured: Beginning of placement of epidural or spinal needle to end of placement: average 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Lack of personnel/research time to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Missouri-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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven T Fogel, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192074
- Sponsor's protocol ID
- 1147418
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2010
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
PubMed 18319185Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
PubMed 17456672Chin KJ, Perlas A, Singh M, Arzola C, Prasad A, Chan V, Brull R. An ultrasound-assisted approach facilitates spinal anesthesia for total joint arthroplasty. Can J Anaesth. 2009 Sep;56(9):643-50. doi: 10.1007/s12630-009-9132-8. Epub 2009 Jun 23.
PubMed 19548051Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
PubMed 14656785Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
PubMed 11421838
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
- ClinicalTrials.gov ID
- NCT01192074
- Acronym / sponsor ID
- 1147418
- Conditions
- Pregnancy
- Keywords
- Obstetric, Analgesia, Anesthesia, Obstetric Anesthesia, Obstetric Analgesia, ultrasound, ultrasonography, epidural analgesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of personnel/research time to recruit participants.
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Aug 2010 (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.
This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.
Detailed description
All patients presenting in labor or are having a cesarean delivery are eligible except: patients who are under age 18, have contraindications to regional anesthesia, in advanced labor, having emergency conditions and/or unable to understand the consent process.
- Data collected include:
- Ultrasound depth in transverse and oblique sagittal views
- Actual needle depth
- Level of placement
- Number of separate needle placements
- Number of needle redirects
- Angle of probe
- Angle of needle
- Total number of attempts
- Pt height
- Pt weight
- Pt BMI
- Pt age
- Pt gravity/parity
- Pt co-morbidities, e.g. pre-eclampsia
- Procedure performed
- Operator (Attending, CA-1, CA-2, CA-3, CRNA)
What is currently being examined is the correlation between ultrasound depth of the target area vs actual needle depth
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound of the spine | – | Device: UltrasoundPregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients in labor Pregnant patients scheduled for cesarean section
Key inclusion criteria (3 listed)
- Pregnant women in labor or scheduled for induction requesting labor epidural analgesia
- Pregnant women scheduled for cesarean delivery
- Pregnant women in labor who are going to have a non-emergent cesarean delivery under spinal anesthesia
Key exclusion criteria (6 listed)
- Emergency delivery
- Emergency cesarean section
- Advanced labor
- Contraindications to neuraxial analgesia/anesthesia
- Unable to understand consent
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 |
|---|---|---|
| UltrasoundPreprocedure ultrasound examination of the spine | Device | Ultrasound of the spine |
Primary outcome
Correlation of Ultrasound vs Needle Depth
Time frame: Beginning of ultrasound exam to end of ultrasound exam: average 5 min
The ultrasound measured depth taken via oblique sagittal views and transverse views of the epidural space for epidural analgesia or intrathecal space for spinal anesthesia will be correlated with actual needle depth
1 secondary outcome
Attempt Number
Time frame: Beginning of placement of epidural or spinal needle to end of placement: average 10 min
Results and safety
The study was stopped early (reason given: Lack of personnel/research time to recruit participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Background: PubMed 18319185Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
- Background: PubMed 17456672Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
- Background: PubMed 19548051Chin KJ, Perlas A, Singh M, Arzola C, Prasad A, Chan V, Brull R. An ultrasound-assisted approach facilitates spinal anesthesia for total joint arthroplasty. Can J Anaesth. 2009 Sep;56(9):643-50. doi: 10.1007/s12630-009-9132-8. Epub 2009 Jun 23.
- Background: PubMed 14656785Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
- Background: PubMed 11421838Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
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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.
Steven T Fogel, MD principal investigator
University of Missouri-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 Pregnancy, run by University of Missouri-Columbia 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 3 inclusion and 6 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 5 Sep 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 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 personnel/research time to recruit participants.). 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?
Correlation of Ultrasound vs Needle Depth (time frame: Beginning of ultrasound exam to end of ultrasound exam: average 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192074, which also lists 5 linked publications.
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 2016.