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.
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.
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:
- Patients' demographic data.
- Obstetrics data.
- Onset of analgesia (attainment of VAS <3).
- HR and MABP (baseline, every 5 minutes until 15 mins, a every 15 mins till 1 hour and then every 1 hour till delivery).
- Visual analogue scale (VAS) with hemodynamics.
- Assessment of sensory level after 30 mins of the block.
- Assessment of Sacral block during the 1st 30 minutes.
- Assessment of motor block through the modified bromage scale
- Occurrence of side effects as: Hypotension, bradycardia, nausea, vomiting and pruritis ,PDPH, nerve injury.
- Conditions
- Dural Puncture Epidural Technique
- 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 group | Role | What they receive |
|---|---|---|
| Conventional epidural group | Active comparator | Conventional epidural.
. Receives: Procedure: Epidural analgesia |
| DPE-25G group | Active comparator | Dural puncture epidural with 25-gauge spinal needle. Receives: Procedure: Epidural analgesia |
| DPE-27G group | Active comparator | Dural 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.
Onset of analgesia
Duration from injection of the first initial epidural bolus dose to attainment of VAS <3
Measured: 20 minutes
Secondary outcomes (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.
- First posted29 Feb 2024
- Study start1 Jan 2021
- Primary completion31 Jan 2022
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural Puncture Epidural TechniqueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mahrous, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block: Comparative Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06287047
- Acronym / sponsor ID
- spinal needle sizes and DPE
- Conditions
- Dural Puncture Epidural Technique
- Keywords
- Dura, Dural puncture, epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Patients' demographic data.
- Obstetrics data.
- Onset of analgesia (attainment of VAS <3).
- HR and MABP (baseline, every 5 minutes until 15 mins, a every 15 mins till 1 hour and then every 1 hour till delivery).
- Visual analogue scale (VAS) with hemodynamics.
- Assessment of sensory level after 30 mins of the block.
- Assessment of Sacral block during the 1st 30 minutes.
- Assessment of motor block through the modified bromage scale
- Occurrence of side effects as: Hypotension, bradycardia, nausea, vomiting and pruritis ,PDPH, nerve injury.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional epidural group | Active comparator | Procedure: Epidural analgesiaConventional epidural. . |
| DPE-25G group | Active comparator | Procedure: Epidural analgesiaDural puncture epidural with 25-gauge spinal needle. |
| DPE-27G group | Active comparator | Procedure: Epidural analgesiaDural puncture epidural with 27-gauge spinal needle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASAI \& II parturient in active labor
- Uncomplicated pregnancy with vertex presentation
- Willing to participate in the study.
Key exclusion criteria (4 listed)
- Patient's refusal
- Coagulopathy (INR> 1.5 and platelets < 80,000)
- Allergy to local anesthetics.
- Prior surgery in lumbosacral spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesiaAlso: Dural punctureEpidural analgesia alone or with dural puncture with different sizes of spinal needles | Procedure or surgery | Conventional epidural group, DPE-25G group, DPE-27G group |
Primary outcome
Onset of analgesia
Time frame: 20 minutes
Duration from injection of the first initial epidural bolus dose to attainment of VAS <3
1 secondary outcome
Degree of analgesia
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.