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

April 25, 2025 updated by: Reham Mahrous, Cairo University

The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • 81 patients primigravida parturients (ASA II) in active labor
  • uncomplicated pregnancy
  • Cephalic presentation
  • Cervical dilatation <5 cm

Exclusion criteria:

  • Allergy to local anesthetics.
  • Bleeding disorders
  • Low platelet count
  • Local or systemic sepsis
  • Prior surgery in lumbosacral spine
  • Patient's refusal.

Eighty-one patients meeting the inclusion criteria were randomly divided into three equal groups:

Group CE (n=27): Conventional epidural. Group DPE-25 (n=27): Dural puncture epidural with 25-gauge spinal needle. Group DPE-27 (n=27): Dural puncture epidural with 27-gauge spinal needle.

Randomization was done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series were unknown to the investigators and the group assignment was kept in a set of sealed envelopes, each bearing only the case number on the outside.

Full medical and surgical history were taken. Laboratory investigations were revised. Visual analogue scale was educated to the patient before the start of the operation.

One liter of lactated Ringer's solution was infused IV over 15 min during the neuraxial procedure.

The procedure was performed in the seated position. Parturients with VAS < 5 were excluded.

The procedure was performed by a senior anesthesia resident.

Before administering medications through the epidural catheter, subarachnoid, intravascular and subdural placement had to be ruled out.

After 5 min of the first initial bolus dose, adequacy of analgesia was assessed.

Analgesia was considered adequate if VAS score is ≤3. Onset of analgesia was defined as from time of first bolus dose to time of achieving VAS ≤3.

Patient with VAS score >3; considered failed block and were excluded from the study.

Analgesia was evaluated by a blinded observer assessing visual analog scale (VAS) pain scores, onset of analgesia, sensory level, and motor blockade.

The primary outcome was the onset of analgesia (defined as duration from injection of the first initial epidural bolus to attainment of VAS <3).

Other data collected are:

  1. Patients' demographic data.
  2. Obstetrics data.
  3. Onset of analgesia (attainment of VAS <3).
  4. HR and MABP (baseline, every 5 minutes until 15 mins, a every 15 mins till 1 hour and then every 1 hour till delivery).
  5. Visual analogue scale (VAS) with hemodynamics.
  6. Assessment of sensory level after 30 mins of the block.
  7. Assessment of Sacral block during the 1st 30 minutes.
  8. Assessment of motor block through the modified bromage scale
  9. Occurrence of side effects as: Hypotension, bradycardia, nausea, vomiting and pruritis ,PDPH, nerve injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medidcne, Cairo Univerisity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional epidural group

Conventional epidural.

.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture
Active Comparator: DPE-25G group
Dural puncture epidural with 25-gauge spinal needle.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture
Active Comparator: DPE-27G group
Dural puncture epidural with 27-gauge spinal needle.
Procedure: Epidural analgesia
Epidural analgesia alone or with dural puncture with different sizes of spinal needles
Other Names:
  • Dural puncture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Onset of analgesia
Time Frame: 20 minutes
Duration from injection of the first initial epidural bolus dose to attainment of VAS <3
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Degree of analgesia
Time Frame: 5 hours
Visual Analogue Score (0-10)
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • spinal needle sizes and DPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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