Effects of; Anesthesia, Spinal and Epidural, in PregnancyNCT02711150
Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy
A study testing PLL Length Measured through US in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
The purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
- What is being tested?
- PLL Length Measured through US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2016to 7 Oct 2016
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Patients
- Term Pregnancy (>37 weeks)
- 18 years or older
- Non-labouring patients, admitted for a cesarean delivery
Who cannot join
- Allergy to ultrasound jelly
- Spinal Deformities
- Active Labour
- Presence of Epidural Catheter for Labour Analgesia
About this study
Official title: Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement
The purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural positioning device applied. For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament will be measured at the L3-L4 interspace.
Read the detailed description
Thirty term pregnant women will be recruited. Signed informed consent will be obtained from all subjects and demographic details, including age, weight, height and body mass index (BMI) will be documented. Randomization and blinding: Randomization will not be performed in this study, because each patient is their own control Interventions: Two experienced operators who have previously performed several hundred landmark-guided and ultrasound-assisted neuraxial blocks will perform the clinical and ultrasound examination.. The patient will then be placed in each of the positions described below. While in each of the positions an ultrasound (US) probe will be placed at level L3- L4 at the paramedian position to visualize the paravertebral longitudinal ligament (PLL) . These measurements will be recorded by an observer. In both phases (first US operator and second US operator ), 2 ultrasound measurements will be made for each of the following positions at 1 lumbar level in the paramedian view. These measurements will be made with the patient in the following positions: • Sitting position, feet supported with back flexed. • Sitting position, feet supported and arms supported through the application of an epidural positioning device. All images will be assigned a number based on a random number generator to remove any identifying data, including volunteer number, date, time, and position. The PLL will be remeasured on every saved image by two separate anesthesiologists ('readers') who are not involved with any previous data collection but are members of the study team. Both will be blinded to the number allocation and each other's measured values. This aim to remove any bias by the 'scanning' anesthesiologists and test for reproducibility in the measurement of the PLL, between 'readers'. A statistician calculated a minimum sample size of 30 subjects, in order to demonstrate significant change in the mean length of the PLL (acoustic target area), in any of the two positions. This estimation was based on data derived from a similar study, which had used a minimum sample size of 16 subjects, with a 1 mm mean change in 'needle target area' dimensions, a 1 mm standard deviation (SD), and an alpha of 0.05 with a power of 90 % [1, 2].
- Being tested
- PLL Length Measured through US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLL Length Measured through USDevice
Also called PLL length
The PLL will be measured for each allocated position: EPD or Flexed Position
| Study group | Role | What they receive |
|---|---|---|
| EPD Measurements | Experimental | Intervention:
PLL Length Measured through US will be done with the subject placed on the Epidural Positioning Device. Receives: Device: PLL Length Measured through US |
| Flexed Position Measurements | Active comparator | Intervention:
PLL Length Measured through US will be done with the subject placed in a "flexed" lumbar spine position. Receives: Device: PLL Length Measured through US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in PLL with the application of an EPD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start3 May 2016
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, Spinal and Epidural, in PregnancyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indu Singh, MD, FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711150
- Sponsor's protocol ID
- 107422
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones AR, Carle C, Columb M. Effect of table tilt on ligamentum flavum length measured using ultrasonography in pregnant women*. Anaesthesia. 2013 Jan;68(1):27-30. doi: 10.1111/anae.12006. Epub 2012 Oct 22.
PubMed 23088766Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. doi: 10.1016/s0952-8180(01)00245-8.
PubMed 11377160
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement
- ClinicalTrials.gov ID
- NCT02711150
- Acronym / sponsor ID
- 107422
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 3 May 2016 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 17 Mar 2016 (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 purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural positioning device applied. For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament will be measured at the L3-L4 interspace.
Detailed description
Thirty term pregnant women will be recruited. Signed informed consent will be obtained from all subjects and demographic details, including age, weight, height and body mass index (BMI) will be documented. Randomization and blinding: Randomization will not be performed in this study, because each patient is their own control Interventions: Two experienced operators who have previously performed several hundred landmark-guided and ultrasound-assisted neuraxial blocks will perform the clinical and ultrasound examination.. The patient will then be placed in each of the positions described below. While in each of the positions an ultrasound (US) probe will be placed at level L3- L4 at the paramedian position to visualize the paravertebral longitudinal ligament (PLL) . These measurements will be recorded by an observer. In both phases (first US operator and second US operator ), 2 ultrasound measurements will be made for each of the following positions at 1 lumbar level in the paramedian view. These measurements will be made with the patient in the following positions: • Sitting position, feet supported with back flexed. • Sitting position, feet supported and arms supported through the application of an epidural positioning device. All images will be assigned a number based on a random number generator to remove any identifying data, including volunteer number, date, time, and position. The PLL will be remeasured on every saved image by two separate anesthesiologists ('readers') who are not involved with any previous data collection but are members of the study team. Both will be blinded to the number allocation and each other's measured values. This aim to remove any bias by the 'scanning' anesthesiologists and test for reproducibility in the measurement of the PLL, between 'readers'. A statistician calculated a minimum sample size of 30 subjects, in order to demonstrate significant change in the mean length of the PLL (acoustic target area), in any of the two positions. This estimation was based on data derived from a similar study, which had used a minimum sample size of 16 subjects, with a 1 mm mean change in 'needle target area' dimensions, a 1 mm standard deviation (SD), and an alpha of 0.05 with a power of 90 % [1, 2].
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPD Measurements | Experimental | Device: PLL Length Measured through USIntervention: PLL Length Measured through US will be done with the subject placed on the Epidural Positioning Device. |
| Flexed Position Measurements | Active comparator | Device: PLL Length Measured through USIntervention: PLL Length Measured through US will be done with the subject placed in a "flexed" lumbar spine position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Patients
- Term Pregnancy (>37 weeks)
- 18 years or older
- Non-labouring patients, admitted for a cesarean delivery
Key exclusion criteria (4 listed)
- Allergy to ultrasound jelly
- Spinal Deformities
- Active Labour
- Presence of Epidural Catheter for Labour Analgesia
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 |
|---|---|---|
| PLL Length Measured through USAlso: PLL lengthThe PLL will be measured for each allocated position: EPD or Flexed Position | Device | EPD Measurements, Flexed Position Measurements |
Primary outcome
Increase in PLL with the application of an EPD
Time frame: 12 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 7 Mar 2018.
- Background: PubMed 23088766Jones AR, Carle C, Columb M. Effect of table tilt on ligamentum flavum length measured using ultrasonography in pregnant women*. Anaesthesia. 2013 Jan;68(1):27-30. doi: 10.1111/anae.12006. Epub 2012 Oct 22.
- Background: PubMed 11377160Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. doi: 10.1016/s0952-8180(01)00245-8.
- Individual participant dataSharing planned: No
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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.
Indu Singh, MD, FRCPC principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing PLL Length Measured through US in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 4 inclusion and 4 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Increase in PLL with the application of an EPD (time frame: 12 months). 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 NCT02711150, which also lists 2 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 7 Mar 2018.