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Clinical Trials in Turkey / NCT07789756
Starting soon Not applicable

Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section

NCT07789756 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-08-27

Condition(s) studied

Cesarean Section (MeSH: D002585)Anesthesia, Spinal (MeSH: D000775)Hypotension (MeSH: D007022)

Investigational drug(s) / intervention(s)

Preprocedural ultrasound level identificationLandmark palpation level identification

Preprocedural ultrasound level identification: Ultrasound-assisted identification and skin marking of the target intervertebral level before spinal needle insertion. Spinal anesthesia is performed with the patient seated, using a midline approach and a pencil-point spinal needle, with hyperbaric bupivacaine and fentanyl dosed according to the Harten table based on maternal height. A maximum of three puncture attempts is permitted.

Landmark palpation level identification: Identification of the target intervertebral level by palpation of Tuffier's line. Spinal anesthesia is performed with the patient seated, using a midline approach and a pencil-point spinal needle, with hyperbaric bupivacaine and fentanyl dosed according to the Harten table based on maternal height. A maximum of three puncture attempts is permitted.

Study summary

This study compares two methods of identifying the correct intervertebral level before performing spinal anesthesia in women undergoing elective cesarean delivery.

In current practice, anesthesiologists locate the puncture site by feeling anatomical landmarks on the lower back (palpation of Tuffier's line). Ultrasound imaging offers an alternative in which the spine is scanned and the intended level is marked on the skin before the needle is inserted. It is not yet clear whether this additional step improves the success of the procedure or affects the mother's blood pressure and heart rate after the block.

Sixty pregnant women scheduled for elective cesarean section will be randomly assigned to one of two groups. In one group, the puncture level will be determined by preprocedural ultrasound marking; in the other, by conventional landmark palpation. All other aspects of anesthetic care, including drug doses, will be identical in both groups.

The main outcome is the proportion of patients in whom the subarachnoid space is entered successfully at the first attempt with a single skin puncture, producing a block adequate for surgery. Additional outcomes include the number of needle passes, procedure duration, changes in maternal blood pressure and heart rate, vasopressor requirement, sensory block level, and complications such as headache or back pain within 24 hours after surgery.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Scheduled for elective cesarean section under spinal anesthesia * Age 18 to 45 years * ASA physical status II or III * Singleton pregnancy * No contraindication to spinal anesthesia * Normotensive * Provides written informed consent Exclusion Criteria: * Emergency cesarean section * Morbid obesity (body mass index 40 kg/m² or higher) * History of lumbar spine surgery * Severe spinal deformity * Local infection at the puncture site * Coagulopathy or ongoing anticoagulant therapy * Anatomical abnormality expected to require multiple puncture attempts

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Kahramanmaraş Onikişubat
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Kahramanmaraş Onikişubat

More Kahramanmaras Sutcu Imam University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07789756 on ClinicalTrials.gov ↗ ← All trials in Turkey