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

NCT ID: NCT06711601

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-10

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Anesthesia Ultrasonography Posterior Superior Iliac Spine Intercristal Line

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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T group

Intercristal line was defined as an Tuffier's line drawn between the tops of both iliac crests. It was considered to intersect the body of L4 or the L4-L5 intervertebral space. The L3-L4 intervertebral space was determined by counting down the level from this line

No interventions assigned to this group

P group

The patient also was palpated the The Posterior Superior Iliac Spine (PSIS), and confirmed the L3-4 intervertebral space position based on the average PI calculated in the first experiment.

No interventions assigned to this group

TP group

confirmed the L3-4 intervertebral space position based on the average PI calculated in the first experiment and Intercristal line.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Souping Wang, PhD

Role: STUDY_DIRECTOR

The Third Affiliated Hospital of Guangzhou Medical University

Locations

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The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhua Zhang, PhD

Role: CONTACT

[email protected]
+86 13611453199

Facility Contacts

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Souping Wang

Role: primary

[email protected]
+86 18988910585

Other Identifiers

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[2024] No. 131

Identifier Type: -

Identifier Source: org_study_id