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PregnancyNCT02616653

Identification of the L3-L4 Intervertebral Space in Obese Parturients

A study testing L3-L4 location: Palpation method confirmed by US in people with Pregnancy and Obesity, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar levels or more) when the palpation method is used in obese parturients at term in the lateral position compared to the sitting position. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Obesity, Obstetrical Anesthesia
What is being tested?
L3-L4 location: Palpation method confirmed by US
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCanada
Study dates
Jan 2016to Feb 2017
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

  • Obese pregnant women (BMI equal or superior to 30)
  • Pregnancy at term (37 weeks or more)

Who cannot join

  • American Society of Anesthesiologists' physical status of 4 or 5
  • Scoliosis or any other anomaly of the spine
  • Prior spine surgery
  • Inability to assume the correct position due to back pain
  • Inability to collaborate
  • Labouring women

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2L4M1

Other trials in Canada

About this study

Official title: Identification of the L3-L4 Intervertebral Space in Obese Parturients at Term in the Sitting and Lateral Positions: Manual Palpation (Tuffier's Line Method) Versus Ultrasound Imaging

This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar levels or more) when the palpation method is used in obese parturients at term in the lateral position compared to the sitting position.

Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two levels higher than the level determined by ultrasonography (US) more often in the lateral than in the sitting position.

Read the detailed description

For years now, anesthesiologists have used anatomical landmarks to guide neuraxial anesthesia and analgesia techniques in obstetric patients. Traditionally, Tuffier's line (intercristal line) has been used as a reference and corresponds to a horizontal line drawn between the upper part of the iliac crests that is thought to intersect the spine at the level of the L4 spinous process or the L4-L5 intervertebral space. However, many studies have found this anatomical landmark to be unreliable reporting the Tuffier's line to intersect the spine at levels ranging from the L3-L4 to L5-S1 intervertebral spaces. Regarding the obstetrical population, the anatomical position of the Tuffier's line was found to be even higher presumably due to the exaggerated lordosis of pregnancy.

Neuraxial techniques used for obstetrical anesthesia and analgesia include epidurals, spinals and combined epidural-spinal (CSE) techniques. The correct identification of the intervertebral space for neuraxial analgesia and anesthesia is very important especially if using a spinal injection such as is done when performing a CSE.

Neuraxial techniques can be done in the sitting or the lying lateral position. When expecting a more challenging technique, such as in an obese patient, anesthesiologists will usually choose to perform the technique with patients in the sitting position. But the lateral position is preferred in certain conditions such as in premature rupture of membranes where there is a risk of umbilical cord prolapse, in women experiencing a vasovagal response caused by the needle insertion or upon assuming the sitting position, or because of the anesthesiologist's preference.

US-guided regional techniques are gaining popularity both for the general population as well as for the pregnant women. It has been shown to be a more reliable tool than the palpation method in identifying a specific lumbar intervertebral level. The use of US imaging for neuraxial techniques in pregnant women has been shown to reduce the numbers of attempts, improve the comfort of the patient during the procedure and increase the precision in identifying the intervertebral space at which the technique is being performed. Obesity can make regional techniques extremely challenging and US imaging becomes a valuable tool in this setting.

Methods:

Participants will be positioned on an exam table in the sitting position for the first half of the group and the lateral position for the other half. For the sitting position, the participants will have both feet supported by a foot rest while being asked to round back by lowering their head on their chest and pushing out their back to assume a fetal like position. If necessary, the women may be asked to hold a pillow to improve their position to get the ideal conditions for the palpation of the Tuffier's line and intervertebral spaces. For the lateral position, the participants will be placed on the left lateral side with flexion of the knees and hip, and flexion of the head and neck with a pillow supporting them. Again, the women will be instructed to adopt a fetal position by rounding their back.

An anesthesiologist who is assigned to the obstetrical floor for the day and who is not an investigator in this study will be asked to perform the palpation method. He/she will proceed with the identification of the Tuffier's line (upper part of the iliac crests) and determine the level of intersection with the spine. This anatomical landmark will then be used to estimate the location of the L3-L4 intervertebral space which is the space frequently chosen to proceed to a neuraxial technique. Once the level is identified, it will be marked and hidden under a hypoallergenic paper tape. The anesthesiologist will then leave the room while the investigator trained in US imaging will proceed to the US exam of the spine specifically aiming to identify the L3-L4 intervertebral space. Once located, the investigator will be able to look at the skin mark made by the anesthesiologist and compare it to the level he/she will have determined to be at the L3-L4 level by US imaging. The investigator will note if the same level was identified and if not, which one was according to the US exam. The paper tape will be reapplied over the lumbar spine to mask any anatomical marks (birth marks or scars) that may influence the anesthesiologist who will be asked to step in again to proceed to the palpation method in the other position, again marking the area which he/she thinks corresponds to the L3-L4 space. US imaging will be repeated in the second position and the level obtained by the exam will be compared to the one obtained by the palpation method in the same way as the first position. The investigators expect the total time for the procedure to be of 20-30 minutes. Participants will be asked to rate their level of comfort during the procedure in both positions using a verbal rating scale from 0 to 10.

Being tested
L3-L4 location: Palpation method confirmed by US
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L3-L4 location: Palpation method confirmed by USProcedure or surgery

    An anesthesiologist will locate the L3-L4 space using the palpation method (Tuffier's line). An investigator trained in US imaging will proceed to the US exam of the spine specifically aiming to identify the L3-L4 intervertebral space. The investigator will note if the same level was identified and if not, which one was according to the US exam.

Study groups in NCT02616653
Study groupRoleWhat they receive
Sitting followed by lateral positionActive comparatorFirst half of participants will be assigned to have their L3-L4 intervertebral space located first in the sitting position followed by the lateral position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)
Receives: Procedure: L3-L4 location: Palpation method confirmed by US
Lateral followed by sitting positionActive comparatorSecond half of participants will be assigned to have their L3-L4 intervertebral space located first in the lateral position followed by the sitting position using the palpation method confirmed by US. (L3-L4 location: Palpation method confirmed by US)
Receives: Procedure: L3-L4 location: Palpation method confirmed by US

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimation of Tuffier's line using the palpation method

    Incidence of overestimation of the Tuffier's line (2 lumbar levels or more) using the palpation method in the sitting position compared to the lateral position

    Measured: On Day one during medical appointment at the obstetrics clinic

Secondary outcomes (2)
  1. Impact of fundal height on estimation of the Tuffier's line using the palpation method

    Impact of fundal height on overestimation of the Tuffier's line using the palpation method in the sitting position compared to the lateral position

    Measured: On Day one during medical appointment at the obstetrics clinic

  2. Comfort level using a verbal rating scale

    Level of comfort during the procedure in the sitting and lateral positions using a verbal rating scale (0 being totally comfortable, 10 totally uncomfortable)

    Measured: On Day one during medical appointment at the obstetrics clinic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616653
Sponsor's protocol ID
15.251
Status last verified
Feb 2017
First submitted
25 Nov 2015
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing L3-L4 location: Palpation method confirmed by US in people with Pregnancy and Obesity, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 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: finished, as of the sponsor's last update on 3 Mar 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 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 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?

Estimation of Tuffier's line using the palpation method (time frame: On Day one during medical appointment at the obstetrics clinic). 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 3 Mar 2017.

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