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NCT Number: NCT06766812

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

epidural set

Device

The epidural space will be identified at either the L3-L4 or L4-L5 interspace using the loss of resistance technique with an 18 Gauge Epidural needle.A test dose of 3 mL of 2% lidocaine with epinephrine will be administered to each participant to rule out intravascular or intrathecal placement of the catheter. This ensures the proper placement of the catheter before the full dose of analgesia is administered.Following the test dose, an initial bolus of 8 mL of 0.25% bupivacaine combined with 2 μg/mL fentanyl will be administered to provide effective labor analgesia. Subsequently, maintenance Dose 0.125% 2 ml/0.5 hr

Primary outcomes

  1. onset of analgesia

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed A zidan, resident

CONTACT

[email protected]

01003707158

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Labour Analgesia in Primigravida;Comparative Randomized Double Blinded Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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