Labor PainNCT06766812
Comparison of Dural Puncture Epidural Versus Conventional Epidural for Labour Analgesia in Primigravida
A study testing epidural set in people with Labor Pain, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- epidural set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Labour Analgesia in Primigravida;Comparative Randomized Double Blinded Study
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.
Read the detailed description
The conventional epidural (CE) technique has been the gold standard for decades, providing continuous and adjustable pain relief during labor. However, the advent of new techniques, such as the Dural Puncture Epidural (DPE) technique, has led to ongoing research and debate over which method offers superior outcomes in terms of efficacy, onset of analgesia, maternal satisfaction, and safety.
The CE technique involves the placement of an epidural catheter into the epidural space, where local anesthetics and adjunctive drugs are administered to provide pain relief. While this technique is highly effective, it is not without limitations. Some parturients may experience a slow onset of analgesia, uneven drug distribution, or the need for frequent catheter adjustments, which can delay adequate pain relief and decrease maternal satisfaction . Furthermore, the CE technique has been associated with potential complications such as unilateral blocks, inadequate sacral analgesia, and the necessity for higher doses of local anesthetics, which may increase the risk of motor blockade and impact labor progression .
In contrast, the DPE technique is a novel approach that modifies the CE by incorporating an intentional dural puncture with a small-gauge spinal needle without administering intrathecal drugs. This modification is believed to facilitate the spread of epidurally administered drugs into the subarachnoid space, potentially enhancing the onset and quality of analgesia. The DPE technique aims to combine the benefits of both the CE and the Combined Spinal Epidural (CSE) techniques while minimizing their respective drawbacks, such as the hemodynamic instability associated with CSE and the slower onset of analgesia often seen with CE
- Conditions
- Labor Pain
- Being tested
- epidural set
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural setDevice
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
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | dural puncture epidural technique in labour analgesia Receives: Device: epidural set |
| group B | Active comparator | conventional epidural technique in labour analgesia Receives: Device: epidural set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Zidan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766812
- Sponsor's protocol ID
- Soh_Med__24_12_03Ms
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28067707Gunaydin 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.
PubMed 30293143
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Labour Analgesia in Primigravida;Comparative Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT06766812
- Acronym / sponsor ID
- Soh_Med__24_12_03Ms
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
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.
Detailed description
The conventional epidural (CE) technique has been the gold standard for decades, providing continuous and adjustable pain relief during labor. However, the advent of new techniques, such as the Dural Puncture Epidural (DPE) technique, has led to ongoing research and debate over which method offers superior outcomes in terms of efficacy, onset of analgesia, maternal satisfaction, and safety.
The CE technique involves the placement of an epidural catheter into the epidural space, where local anesthetics and adjunctive drugs are administered to provide pain relief. While this technique is highly effective, it is not without limitations. Some parturients may experience a slow onset of analgesia, uneven drug distribution, or the need for frequent catheter adjustments, which can delay adequate pain relief and decrease maternal satisfaction . Furthermore, the CE technique has been associated with potential complications such as unilateral blocks, inadequate sacral analgesia, and the necessity for higher doses of local anesthetics, which may increase the risk of motor blockade and impact labor progression .
In contrast, the DPE technique is a novel approach that modifies the CE by incorporating an intentional dural puncture with a small-gauge spinal needle without administering intrathecal drugs. This modification is believed to facilitate the spread of epidurally administered drugs into the subarachnoid space, potentially enhancing the onset and quality of analgesia. The DPE technique aims to combine the benefits of both the CE and the Combined Spinal Epidural (CSE) techniques while minimizing their respective drawbacks, such as the hemodynamic instability associated with CSE and the slower onset of analgesia often seen with CE
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: epidural setdural puncture epidural technique in labour analgesia |
| group B | Active comparator | Device: epidural setconventional epidural technique in labour analgesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 setThe 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 | Device | group A, group B |
Primary outcome
onset of analgesia
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 28067707Chau 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.
- Background: PubMed 30293143Gunaydin 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.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing epidural set in people with Labor Pain, run by Sohag University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed A zidan, resident (01003707158, mohamed_zidan_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of analgesia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766812, which also lists 2 linked publications.
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 15 Jan 2025.