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Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section

NCT07789756 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-08-27

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Kahramanmaras Sutcu Imam University

    lead OTHER

Principal Investigators

  • Feyza Çalışır · Kahramanmaras Sutcu Imam University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789756 on ClinicalTrials.gov