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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277988
• Other study ID #: 107570
• Status: Completed
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLL length	Length of the Paravertebral Longitudinal Ligament, as measured by the intrinsic ultrasound caliber tool in mm.	Up to Five minutes
Secondary	LF length	Length of the Ligamentum Flavum as measured by the intrinsic ultrasound caliber tool in mm.	Up to Five minutes
Secondary	ILD length	Length of the interlaminar distance, as measured by the intrinsic ultrasound caliber tool in mm.	Up to Five minutes
Secondary	Patient Comfort	Patient comfort level measured on a 1-5 Likert Scale	Up to 5 minutes