Dural Puncture Epidural vs Standard Epidural Analgesia in Labor
NCT ID: NCT07278895
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-12-18
2026-03-02
Brief Summary
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Detailed Description
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The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction.
Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure.
The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dural Puncture Epidural (DPE)
Participants receive Dural Puncture Epidural analgesia using a 27G Whitacre spinal needle inserted through the Tuohy needle before epidural catheter placement, without intrathecal drug administration.
Dural Puncture Epidural (DPE)
The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Standard Epidural Analgesia
Participants in this arm receive Standard Epidural Analgesia. The epidural block is performed using a Tuohy needle without dural puncture, and an epidural catheter is inserted into the epidural space. After a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Standard Epidural Analgesia
Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Interventions
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Dural Puncture Epidural (DPE)
The Dural Puncture Epidural (DPE) technique is performed by inserting a 27-gauge Whitacre spinal needle through the Tuohy epidural needle to puncture the dura without intrathecal drug injection. After removal of the spinal needle, an epidural catheter is placed, and following a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Standard Epidural Analgesia
Standard Epidural Analgesia is performed using a Tuohy needle without dural puncture. An epidural catheter is inserted into the epidural space, and after a negative test dose, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered.
Eligibility Criteria
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Inclusion Criteria
2. Requesting neuraxial labor analgesia.
3. Age between 18 and 45 years.
4. ASA physical status I-II.
5. Cervical dilation ≥ 4 cm at the time of enrollment.
6. Cervical effacement ≥ 50-60%.
7. Baseline pain score of VAS ≥ 3.
8. Ability to provide informed consent.
Exclusion Criteria
2. Placental abnormalities (placenta previa, placental abruption, etc.).
3. Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
4. Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
5. Morbid obesity (Body Mass Index ≥ 40 kg/m²).
6. Opioid dependence or chronic opioid use.
7. Accidental dural puncture with the epidural needle prior to randomization.
8. Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
9. Fetal distress at the time of enrollment.
10. Patient refusal to participate.
11. Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.
\-
18 Years
45 Years
FEMALE
No
Sponsors
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
OTHER
Responsible Party
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Mehmet Baran
Clinical Investigator
Central Contacts
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References
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Pazur I, Ozegic O, Lijovic L, Jaic KK, Pesic M. The Efficacy of Dural Puncture Epidural Performed by 27-gauge Whitacre Needle in Labour Epidural Analgesia: Randomized Single-Blinded Controlled Study. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):304-310. doi: 10.4274/TJAR.2023.221085.
Other Identifiers
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423
Identifier Type: -
Identifier Source: org_study_id