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OpenTrials
Completed

NCT Number: NCT04277988

Effect of Crossed Legged Position on Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients.

To investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to the standard sitting flexed position.

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Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

This is a prospective observational study involving a total of 30 healthy term gestation pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed leg or in standard position first. Using ultrasonography, the acoustic window for lumbar spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg positions. Ultrasonography will be performed sequentially to measure the best visualized length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the paramedian view.The scanned image will be saved to be remeasured by a third observer. Patients will be asked to score their comfort level while sitting in both positions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Term gestation Singleton pregnancy 18 years or older Patients having elective cesarean delivery or induction of labor or in early labor

Exclusion criteria

  • Allergy to ultrasound jelly
  • Spinal Deformities/Previous spinal surgery
  • No contraindication to neuraxial placement
  • Any fetal concerns
  • Morbid obesity
  • Language barrier

Treatment and study plan

Ultrasonography

Device

Length of Posterior Longitudianl Ligament, Ligamentum Flavum and Interlaminar distance visible in paramedian longitudinal view during lumbar spine ultrasonography in cross legged position will be compared to standard sitting position.

Primary outcomes

  1. PLL length

    Time frame: Up to Five minutes

    Length of the Paravertebral Longitudinal Ligament, as measured by the intrinsic ultrasound caliber tool in mm.

Secondary outcomes

  1. LF length

    Time frame: Up to Five minutes

    Length of the Ligamentum Flavum as measured by the intrinsic ultrasound caliber tool in mm.

  2. ILD length

    Time frame: Up to Five minutes

    Length of the interlaminar distance, as measured by the intrinsic ultrasound caliber tool in mm.

  3. Patient Comfort

    Time frame: Up to 5 minutes

    Patient comfort level measured on a 1-5 Likert Scale

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Comparison of the Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients in the Standard Sitting and Crossed Leg Positions: an Observational Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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