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NOT YET RECRUITING
NCT07789756
NA

Ultrasound Versus Palpation for Determining Spinal Puncture Level in Cesarean Section

Sponsor: Kahramanmaras Sutcu Imam University

View on ClinicalTrials.gov

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.

Official title: Comparison of Ultrasound and Palpation for Determining the Level of Entry in Spinal Anesthesia for Cesarean Section: Technical Success, Level Accuracy and Maternal Hemodynamic Response - A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-09-01

Completion Date

2027-09

Last Updated

2026-08-27

Healthy Volunteers

Yes

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.

Locations (2)

Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital

Kahramanmaraş, Onikişubat, Turkey (Türkiye)

Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital

Kahramanmaraş, Onikişubat, Turkey (Türkiye)