Ultrasound Evaluation of Two Anatomic Landmarks in Spinal Anesthesia for Cesarean Section: the Posterior Superior Iliac Spine VS Iliac Crest

Recruiting

• Conditions: Spinal Anesthesia; Ultrasonography; Posterior Superior Iliac Spine; Intercristal Line

• Registration Number: NCT06711601
• Lead Sponsor: The Third Affiliated Hospital of Guangzhou Medical University

Brief Summary

Intercristal line as palpation landmarks to identifying the vertebral level is frequently inaccurate.To find more safe and reliable body surface markers and convenient methods to be solved in clinical work.The investigators performed a two-stage study to evaluated the accuracy of intercristal line and the The Posterior Superior Iliac Spine (PSIS) line to identify the lumbar intervertebral space for spinal anesthesia using ultrasonography in pregnant woman which will provide a second option.

Detailed Description

The investigators performed a two-stage study to evaluated the accuracy of Intercristal line and the PSIS line to identify the lumbar intervertebral space for spinal anesthesia using ultrasonography in pregnant woman. In phase 1, the distance between the PSIS line and each intervertebral space(PI) is measured by ultrasound,and the mean and 95% confidence interval of PI in pregnant women with different height ranges were calculated to provide a reference for identifying specific lumbar spaces.In phase 2, a further 180 participants were received the PSIS, Intercristal line or both as palpation landmarks to define specific lumbar spaces.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-10-10
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• After obtaining written informed consents,pregnant women at 37-41 weeks of gestation

Exclusion Criteria

• The patients have contraindications to intraspinal anesthesia , if their lumbar anatomy was potentially compromised by spinal scoliosis, spondylolisthesis, severe disc height reduction, sacralization,lumbarization, previous spinal surgery or osteoporosis with loss of vertebral height or if the patient with BMI greater than 35 could not be palpated with a clear intervertebral space

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distance between the PSIS line and each intervertebral space(PI)	three days	PSIS line was defined as an intercristal line drawn between the the final posterior superior iliac spine point.Use a ruler to measure the distance between the PSIS line and each intervertebral space(PI)and record. The mean of PI and 95% confidence interval are calculated.
The accuracy of the anatomic landmarks to determine the L3- L4 intervertebral space	three days	The L3-L4 intervertebral space was detected using intercristal line and the PSIS line in a random order by 2 experienced anesthesiologists. After determining the L3-L4 intervertebral space using each method alternately, horizontal skin marks were created with an erasable pen. Then, another experienced anesthesiologist for ultrasonographic examination assessed the intervertebral spaces.After identifying the sacrum, the investigator moved the probe in a cephalad direction, counted the intervertebral spaces and assessed the actual intervertebral spaces of the 2 skin marks.

Secondary Outcome Measures

Name	Time	Method
the location of the palpated intercristal line.	three days	The experienced anesthesiologist for ultrasonographic examination assessed the actual intervertebral spaces of the intercristal line.
baseline data	three days	the gestational weeks

Trial Locations

Locations (1)

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China