Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Classic Intercristal Line Technique; Other: Novel SAIL Technique

• Registration Number: NCT03433612
• Lead Sponsor: University of Michigan

Brief Summary

This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.

Detailed Description

The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.

The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.

Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-02-15
• Primary Completion: 2018-06-28
• Status Verified: 2018-10
• Study Completion: 2018-10-30
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Ultrasound-determined gestation age greater than or equal to 37 weeks
• Expressed interest or indication for epidural anesthesia
• Patients in the first stage of labor

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Exclusion Criteria

• Patients perceived or indicating that she is unable to cooperate with positioning
• BMI greater than 45 kg/m2
• Previous spine surgery or known spinal deformities
• Impaired decision making abilities
• non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	Novel SAIL Technique	Estimates of the location of the L4-L5 intervertebral space will be done by the classic intercristal line technique and novel SAIL technique. Each technique will be performed by different randomly assigned investigators. \* Both techiques will be assessed on all patients
All Patients	Classic Intercristal Line Technique	Estimates of the location of the L4-L5 intervertebral space will be done by the classic intercristal line technique and novel SAIL technique. Each technique will be performed by different randomly assigned investigators. \* Both techiques will be assessed on all patients

Primary Outcome Measures

Name	Time	Method
Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace	From enrollment to the end of data collection, approximately 15 minutes	Percentage of trials for the novel and classic technique respectively that the estimation correctly matches the L4-L5 interspace as determined by lumbar paramedian ultrasound will serve as a measure of accuracy

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States