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

NCT03433612 | Completed

• 1 other identifier: HUM00109509
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Anatomical Landmarks

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Patients

OTHER

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

Other: Classic Intercristal Line Technique; Other: Novel SAIL Technique

Interventions

Classic Intercristal Line Technique OTHER

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.

Also known as: Standard of Care

All Patients

Novel SAIL Technique OTHER

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.

Also known as: Experimental

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Pancaro C, Rajala B, Vahabzadeh C, Cassidy R, Klumpner TT, Kountanis JA, McCabe M, Rector D, Aman C, Sankar K, Schoenfeld R, Engoren M. Sacral anatomical interspace landmark for lumbar puncture in pregnancy: A randomized trial. Neurology. 2020 Feb 11;94(6):e626-e634. doi: 10.1212/WNL.0000000000008749. Epub 2019 Dec 12.

  PMID: 31831599 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carlo Pancaro, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The estimation marks from each technique (two total) will be on the back of the patient (one on the left flank, one on the right flank), therefore the patient does not know where the marks are. Additionally, each mark will be covered with a taped on gauze pad to conceal it so that the two investigators are blinded to each others assessment. The ultrasound clinician will be masked to the two estimations. The marks will still remain covered while the interspace is determined by the third assessor using lumbar ultrasound.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrical Anesthesiology

Model Details: All patients will undergo estimation of the L4-L5 interspace using the classic and novel technique, followed by identification of the interspace using lumbar ultrasound.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: February 15, 2018
• Primary Completion: June 28, 2018
• Study Completion: October 30, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)