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NOT YET RECRUITING
NCT07883733
NA

Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality

Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare three regional anesthesia techniques (spinal, epidural, and dural puncture epidural anesthesia) in healthy pregnant women undergoing planned (elective) cesarean delivery. The main questions it aims to answer are: Which technique causes less low blood pressure (maternal hypotension) and requires less vasopressor medication during surgery? Which technique provides faster and more effective surgical anesthesia? Spinal anesthesia works quickly but often causes a sudden drop in blood pressure, while epidural anesthesia is more stable but slower and sometimes incomplete. Dural puncture epidural is a newer technique that may combine the speed of spinal anesthesia with the stability of epidural anesthesia. A total of 120 participants will be randomly assigned in equal numbers to one of the three groups. Researchers will compare the groups for blood pressure and heart rate changes, number of hypotension episodes, vasopressor use, time to reach adequate block (T6 level), block quality, need for additional pain medication, and side effects such as nausea, vomiting, and headache. Newborn well-being will be assessed with Apgar scores and umbilical cord blood gas analysis. Maternal and surgeon satisfaction will also be recorded.

Official title: Effects of Spinal, Epidural, and Dural Puncture Epidural Anesthesia on Maternal Hemodynamics and Block Efficacy in Cesarean Delivery: A Prospective Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-12-01

Completion Date

2027-10-01

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

PROCEDURE

Spinal Anesthesia

Single-shot intrathecal injection of 10 mg 0.5% hyperbaric bupivacaine plus 10 mcg fentanyl.

PROCEDURE

Epidural Anesthesia

Epidural catheter placement followed by incremental administration of local anesthetic and fentanyl through the catheter.

PROCEDURE

Dural Puncture Epidural Anesthesia

Dural puncture with a 27G spinal needle without intrathecal drug injection, followed by epidural catheter placement and administration of local anesthetic and fentanyl through the catheter.

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)