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

NCT04277988 | Completed

• 1 other identifier: 107570
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy

Keywords

Maternal Analgesia; Ultrasonography Lumbar Spine

Outcome Measures

Primary Outcomes (1)

• PLL length

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

  Up to Five minutes

Secondary Outcomes (3)

• LF length

  Up to Five minutes

• ILD length

  Up to Five minutes

• Patient Comfort

  Up to 5 minutes

Study Arms (2)

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

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

Interventions

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.

Crossed leg position; Standard Sitting position

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant patients at term in the Labour and Delivery Suite, as well as those booked for elective cesarean sections who meet the inclusion criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Indu Singh, FRCPC

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: February 20, 2020
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 20, 2020

Record last verified: 2015-12