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Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02711150
Collaborator
(none)
30
Enrollment
2
Arms
5.2
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: PLL Length Measured through US
 N/A

Detailed 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].

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement
Actual Study Start Date :
May 3, 2016
Actual Primary Completion Date :
Oct 7, 2016
Actual Study Completion Date :
Oct 7, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: EPD Measurements

Intervention: PLL Length Measured through US will be done with the subject placed on the Epidural Positioning Device.

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

    		•
    Active Comparator: Flexed Position Measurements

    Intervention: PLL Length Measured through US will be done with the subject placed in a "flexed" lumbar spine position.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Increase in PLL with the application of an EPD [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Indu Singh, MD, FRCPC, Western University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02711150
    Other Study ID Numbers:
    • 107422
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 7, 2018