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

Pregnancy Related Clinical Trial

— SAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433612
• Other study ID #: HUM00109509
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: October 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 30, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Classic Intercristal Line Technique
Researcher will use the classic technique to estimate the L4-L5 interspace. The classic technique begins by palpating both the right and left posterior iliac crests and following the imaginary line that intersects each (intercristal line) with the non-dominant hand to the spine where it is estimated to intersect the L4 spinous process or L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.
• Novel SAIL Technique
Researcher will use the novel technique to estimate the L4-L5 interspace. The SAIL technique begins by palpating the sacrum and the researcher sliding the non-dominant hand up the dorsal surface of the sacrum to the first interspace (L5-S1) and then up one more interspace to estimate the L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace	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	From enrollment to the end of data collection, approximately 15 minutes