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

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University of Michigan

Status

Completed

Conditions

Pregnancy Related

Treatments

Other: Novel SAIL Technique
Other: Classic Intercristal Line Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03433612
HUM00109509

Details and patient eligibility

About

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.

Full 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).

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

110 participants in 1 patient group

All Patients
Other group
Description:
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
Treatment:
Other: Classic Intercristal Line Technique
Other: Novel SAIL Technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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