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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04277988
Collaborator
(none)
30
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasonography

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Comparison of the Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients in the Standard Sitting and Crossed Leg Positions: an Observational Study
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Crossed leg position

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.

Device: Ultrasonography
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.

Standard Sitting position

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.

Device: Ultrasonography
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. LF length [Up to Five minutes]

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

  2. ILD length [Up to Five minutes]

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

  3. Patient Comfort [Up to 5 minutes]

    Patient comfort level measured on a 1-5 Likert Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Indu Singh, FRCPC, Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT04277988
Other Study ID Numbers:
  • 107570
First Posted:
Feb 20, 2020
Last Update Posted:
Feb 20, 2020
Last Verified:
Dec 1, 2015
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Lawson Health Research Institute

Study Results

No Results Posted as of Feb 20, 2020