About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Scheduled for elective cesarean section under spinal anesthesia
Age 18 to 45 years
ASA physical status II or III
Singleton pregnancy
Disqualifiers
Emergency cesarean section
Morbid obesity (body mass index 40 kg/m² or higher)
History of lumbar spine surgery
Severe spinal deformity
Trial design
Parallel
Treatments tested in this trial
Preprocedural ultrasound level identification
Procedure/SurgeryUltrasound-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
Procedure/SurgeryIdentification 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.
Treatment groups
Trial outcomes
Primary outcomes
First-attempt success rate
Successful dural puncture (CSF flow) with a single skin puncture at the selected level, with adequate surgical block and no need for supplemental analgesia or GA.
Secondary outcomes
Number of skin punctures and needle redirections
Number of skin punctures and number of needle redirections required to achieve dural puncture
Procedure duration
Time from needle-skin contact to visualization of cerebrospinal fluid
Incidence of hypotension
Mean arterial pressure below 65 mmHg or a decrease of 20% or more from baseline
Total ephedrine dose
Sponsors and contacts
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