NCT06849726

Epidural vs. Dural Puncture Epidural in Labor Analgesia

Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction

Detailed description

The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS \< 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction

Conditions

• Labor Pain
• Epidural Analgesia

Interventions

Type	Name	Description
PROCEDURE	Standard Epidural Analgesia	Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.
PROCEDURE	Dural Puncture Epidural Analgesia	Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by the same standardized dose of bupivacaine with fentanyl.

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-10-20
• Completion: 2025-12-20
• First posted: 2025-02-27
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)