NCT07278895

Dural Puncture Epidural vs Standard Epidural Analgesia in Labor

A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.

Detailed description

This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose. The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction. Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure. The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.

Conditions

• Pregnancy Related
• Analgesia, Epidural
• Labor Pain

Interventions

Type	Name	Description
PROCEDURE	Dural Puncture Epidural (DPE)	The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
PROCEDURE	Standard Epidural Analgesia	Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-04-03
• Completion: 2026-04-06
• First posted: 2025-12-12
• Last updated: 2026-04-07

Locations

1 site across 1 country: Turkey (Türkiye)