Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy
Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedStudy Start
First participant enrolled
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2016
CompletedMarch 7, 2018
March 1, 2018
5 months
January 26, 2016
March 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Increase in PLL with the application of an EPD
12 months
Study Arms (2)
EPD Measurements
EXPERIMENTALIntervention: PLL Length Measured through US will be done with the subject placed on the Epidural Positioning Device.
Flexed Position Measurements
ACTIVE COMPARATORIntervention: PLL Length Measured through US will be done with the subject placed in a "flexed" lumbar spine position.
Interventions
The PLL will be measured for each allocated position: EPD or Flexed Position
Eligibility Criteria
You may qualify if:
- Female Patients
- Term Pregnancy (\>37 weeks)
- years or older
- Non-labouring patients, admitted for a cesarean delivery
You may not qualify if:
- Allergy to ultrasound jelly
- Spinal Deformities
- Active Labour
- Presence of Epidural Catheter for Labour Analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 23088766BACKGROUNDGrau 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. doi: 10.1016/s0952-8180(01)00245-8.
PMID: 11377160BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Indu Singh, MD, FRCPC
Western University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2016
First Posted
March 17, 2016
Study Start
May 3, 2016
Primary Completion
October 7, 2016
Study Completion
October 7, 2016
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share