The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block

NCT06287047 | Completed

• 1 other identifier: spinal needle sizes and DPE
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications.

Conditions

Dural Puncture Epidural Technique

Keywords

Dura; Dural puncture; epidural

Outcome Measures

Primary Outcomes (1)

• Onset of analgesia

  Duration from injection of the first initial epidural bolus dose to attainment of VAS \<3

  20 minutes

Secondary Outcomes (1)

• Degree of analgesia

  5 hours

Study Arms (3)

Conventional epidural group

ACTIVE COMPARATOR

Conventional epidural. .

Procedure: Epidural analgesia

DPE-25G group

ACTIVE COMPARATOR

Dural puncture epidural with 25-gauge spinal needle.

Procedure: Epidural analgesia

DPE-27G group

ACTIVE COMPARATOR

Dural puncture epidural with 27-gauge spinal needle.

Procedure: Epidural analgesia

Interventions

Epidural analgesia PROCEDURE

Epidural analgesia alone or with dural puncture with different sizes of spinal needles

Also known as: Dural puncture

Conventional epidural group; DPE-25G group; DPE-27G group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Parturients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASAI \& II parturient in active labor
• Uncomplicated pregnancy with vertex presentation
• Willing to participate in the study.

You may not qualify if:

• Patient's refusal
• Coagulopathy (INR\> 1.5 and platelets \< 80,000)
• Allergy to local anesthetics.
• Prior surgery in lumbosacral spine.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medidcne, Cairo Univerisity

Cairo, Egypt

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: February 29, 2024
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: June 15, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)