Comparison of Dural Puncture Epidural Versus Conventional Epidural for Labour Analgesia in Primigravida

Not Applicable

Not yet recruiting

• Conditions: Labor Pain

• Registration Number: NCT06766812
• Lead Sponsor: Sohag University

Brief Summary

This study aims to compare the analgesic efficacy and safety of the Dural Puncture Epidural (DPE) technique versus the Conventional Epidural (CE) technique for labor analgesia in primigravida.

Detailed Description

The conventional epidural (CE) technique has been the gold standard for decades, providing continuous and adjustable pain relief during labor. However, the advent of new techniques, such as the Dural Puncture Epidural (DPE) technique, has led to ongoing research and debate over which method offers superior outcomes in terms of efficacy, onset of analgesia, maternal satisfaction, and safety.

The CE technique involves the placement of an epidural catheter into the epidural space, where local anesthetics and adjunctive drugs are administered to provide pain relief. While this technique is highly effective, it is not without limitations. Some parturients may experience a slow onset of analgesia, uneven drug distribution, or the need for frequent catheter adjustments, which can delay adequate pain relief and decrease maternal satisfaction . Furthermore, the CE technique has been associated with potential complications such as unilateral blocks, inadequate sacral analgesia, and the necessity for higher doses of local anesthetics, which may increase the risk of motor blockade and impact labor progression .

In contrast, the DPE technique is a novel approach that modifies the CE by incorporating an intentional dural puncture with a small-gauge spinal needle without administering intrathecal drugs. This modification is believed to facilitate the spread of epidurally administered drugs into the subarachnoid space, potentially enhancing the onset and quality of analgesia. The DPE technique aims to combine the benefits of both the CE and the Combined Spinal Epidural (CSE) techniques while minimizing their respective drawbacks, such as the hemodynamic instability associated with CSE and the slower onset of analgesia often seen with CE

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-01-13
• Study Start: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Primigravida women aged 18-40 years.
2. Gestational age between 37 and 42 weeks.
3. Single pregnancy with vertex presentation.
4. Patients in active labor with cervical dilation of less than 5 cm at the time of epidural placement.
5. American Society of Anesthesiologist physical status I or II.
6. Patients who provide informed consent for participation in the study.

Exclusion Criteria

1. Patients with contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at the puncture site).
2. History of preeclampsia, gestational diabetes, or any other significant medical conditions that could influence labor or anesthesia outcomes.
3. Patients with a history of previous uterine surgery, including cesarean section.
4. Known fetal anomalies or non- vertex presentations.
5. Patients with morbid obesity (BMI > 40 kg/m²).
6. Allergy or hypersensitivity to local anesthetic-s used in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
onset of analgesia	1 year	be th; e onset of effective Analgesia , defined; as the time from the administration of the initial epidural bolus to a reduction in Visual Analogue Scale pain score to less than 3