Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

Official title:

Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711150
• Other study ID #: 107422
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: March 5, 2018
• Start date: May 3, 2016
• Est. completion date: October 7, 2016

Study information

• Verified date: March 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural positioning device applied. For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament will be measured at the L3-L4 interspace.

Description:

Thirty term pregnant women will be recruited. Signed informed consent will be obtained from all subjects and demographic details, including age, weight, height and body mass index (BMI) will be documented. Randomization and blinding: Randomization will not be performed in this study, because each patient is their own control Interventions: Two experienced operators who have previously performed several hundred landmark-guided and ultrasound-assisted neuraxial blocks will perform the clinical and ultrasound examination.. The patient will then be placed in each of the positions described below. While in each of the positions an ultrasound (US) probe will be placed at level L3- L4 at the paramedian position to visualize the paravertebral longitudinal ligament (PLL) . These measurements will be recorded by an observer. In both phases (first US operator and second US operator ), 2 ultrasound measurements will be made for each of the following positions at 1 lumbar level in the paramedian view. These measurements will be made with the patient in the following positions: • Sitting position, feet supported with back flexed. • Sitting position, feet supported and arms supported through the application of an epidural positioning device. All images will be assigned a number based on a random number generator to remove any identifying data, including volunteer number, date, time, and position. The PLL will be remeasured on every saved image by two separate anesthesiologists ('readers') who are not involved with any previous data collection but are members of the study team. Both will be blinded to the number allocation and each other's measured values. This aim to remove any bias by the 'scanning' anesthesiologists and test for reproducibility in the measurement of the PLL, between 'readers'. A statistician calculated a minimum sample size of 30 subjects, in order to demonstrate significant change in the mean length of the PLL (acoustic target area), in any of the two positions. This estimation was based on data derived from a similar study, which had used a minimum sample size of 16 subjects, with a 1 mm mean change in 'needle target area' dimensions, a 1 mm standard deviation (SD), and an alpha of 0.05 with a power of 90 % [1, 2].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female Patients

• Term Pregnancy (>37 weeks)

• 18 years or older

• Non-labouring patients, admitted for a cesarean delivery

Exclusion Criteria:

• Allergy to ultrasound jelly

• Spinal Deformities

• Active Labour

• Presence of Epidural Catheter for Labour Analgesia

Related Conditions & MeSH terms

• Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Intervention

Device:
• PLL Length Measured through US
The PLL will be measured for each allocated position: EPD or Flexed Position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

References & Publications (2)

Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. — View Citation

Jones AR, Carle C, Columb M. Effect of table tilt on ligamentum flavum length measured using ultrasonography in pregnant women*. Anaesthesia. 2013 Jan;68(1):27-30. doi: 10.1111/anae.12006. Epub 2012 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in PLL with the application of an EPD		12 months