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

NCT06766812 | Not Yet Recruiting

• 1 other identifier: Soh_Med__24_12_03Ms
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• onset of analgesia

  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

  1 year

Study Arms (2)

group A

ACTIVE COMPARATOR

dural puncture epidural technique in labour analgesia

Device: epidural set

group B

ACTIVE COMPARATOR

conventional epidural technique in labour analgesia

Device: epidural set

Interventions

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

group A; group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (2)

• Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.

  PMID: 28067707 BACKGROUND

• Gunaydin B, Erel S. How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. J Anesth. 2019 Feb;33(1):125-130. doi: 10.1007/s00540-018-2564-y. Epub 2018 Oct 6.

  PMID: 30293143 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed A zidan, resident

CONTACT

01003707158; mohamed_zidan_post@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-anesethiology department-sohag hospital university

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: January 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share