Clinical trial NCT06711601: Ultrasound Evaluation of Two Anatomic Landmarks in Spinal Anesthesia for Cesarean Section: the Posterior Superior Iliac Spine VS Iliac Crest
Official title: Ultrasound Evaluation of Two Anatomic Landmarks in Spinal Anesthesia for Cesarean Section: the Posterior Superior Iliac Spine Vs Iliac Crest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Anesthesia
Ultrasonography
Posterior Superior Iliac Spine
Intercristal Line
Keywords: cesarean section
ultrasonography
spinal anesthesia
Posterior Superior Iliac Spine
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at 37-41 weeks of gestation

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.

Eligibility criteria: 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

Primary outcomes:
measure: The distance between the PSIS line and each intervertebral space(PI)
timeFrame: three days
measure: The accuracy of the anatomic landmarks to determine the L3- L4 intervertebral space
timeFrame: three days
Secondary outcomes:
measure: the location of the palpated intercristal line.
timeFrame: three days
measure: baseline data
timeFrame: three days
measure: baseline data
timeFrame: three days
measure: baseline data
timeFrame: three days
measure: baseline data
timeFrame: three days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Guangzhou Medical University
name: Souping Wang, PhD
role: STUDY_DIRECTOR
References: