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

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