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

Completed

• Conditions: Pregnancy
• Interventions: Device: Ultrasonography

• Registration Number: NCT04277988
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2016-03
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crossed leg position	Ultrasonography	Patients in this group will be randomly allocated to sit in crossed leg position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements.
Standard Sitting position	Ultrasonography	Patients in this group will be randomly allocated to sit in standard position first.Ultrasonography will be performed in this position to measure the best visualized length of posterior longitudinal ligament, ligamentum flavum and interlaminar distance at L3-4 lumbar level as by Operator 1 . These measurements will be recorded by Operator 2 using intrinsic caliper software.Operator 1 will not be told the measurements.

Primary Outcome Measures

Name	Time	Method
PLL length	Up to Five minutes	Length of the Paravertebral Longitudinal Ligament, as measured by the intrinsic ultrasound caliber tool in mm.

Secondary Outcome Measures

Name	Time	Method
Patient Comfort	Up to 5 minutes	Patient comfort level measured on a 1-5 Likert Scale
LF length	Up to Five minutes	Length of the Ligamentum Flavum as measured by the intrinsic ultrasound caliber tool in mm.
ILD length	Up to Five minutes	Length of the interlaminar distance, as measured by the intrinsic ultrasound caliber tool in mm.