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Dural Puncture Epidural TechniqueNCT06287047

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

A study testing Epidural analgesia in people with Dural Puncture Epidural Technique, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Dural Puncture Epidural Technique
What is being tested?
Epidural analgesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteEgypt
Study dates
1 Jan 2021to 15 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medidcne, Cairo Univerisity

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read the 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.
Being tested
Epidural analgesia
Keywords
Dura, Dural puncture, epidural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural analgesiaProcedure or surgery

    Also called Dural puncture

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

Study groups in NCT06287047
Study groupRoleWhat they receive
Conventional epidural groupActive comparatorConventional epidural. .
Receives: Procedure: Epidural analgesia
DPE-25G groupActive comparatorDural puncture epidural with 25-gauge spinal needle.
Receives: Procedure: Epidural analgesia
DPE-27G groupActive comparatorDural puncture epidural with 27-gauge spinal needle.
Receives: Procedure: Epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Onset of analgesia

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

    Measured: 20 minutes

Secondary outcomes (1)
  1. Degree of analgesia

    Visual Analogue Score (0-10)

    Measured: 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start1 Jan 2021
  3. Primary completion31 Jan 2022
  4. Study completion15 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287047
Sponsor's protocol ID
spinal needle sizes and DPE
Status last verified
Apr 2025
First submitted
23 Feb 2024
Last updated
29 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epidural analgesia in people with Dural Puncture Epidural Technique, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of analgesia (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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