Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorKahramanmaras Sutcu Imam University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Preprocedural ultrasound level identification

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Ultrasound GroupExperimental treatment 1 intervention
Group B: Palpation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During spinal procedure (up to 30 minutes)

Secondary outcomes

1

Number of skin punctures and needle redirections

Number of skin punctures and number of needle redirections required to achieve dural puncture

Time frame
During the spinal procedure, up to 30 minutes
2

Procedure duration

Time from needle-skin contact to visualization of cerebrospinal fluid

Time frame
During the spinal procedure, up to 30 minutes
3

Incidence of hypotension

Mean arterial pressure below 65 mmHg or a decrease of 20% or more from baseline

Time frame
From intrathecal injection to end of surgery, up to 90 minutes
4

Total ephedrine dose

Time frame
From intrathecal injection to end of surgery, up to 90 minutes

Other outcomes

Sponsors and contacts

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