Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
NCT Number: NCT07278895
This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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 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.
Time frame: Within 30 minutes after epidural bolus
Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS < 3, indicating effective labor analgesia.
Time frame: Within 30 minutes after epidural bolus
The highest dermatome level of sensory block assessed by pinprick or cold test.
Time frame: Within 30 minutes after epidural bolus
Degree of motor block measured using the Bromage scale (0-3).
Time frame: During labor until delivery
Number of additional boluses required when VAS ≥ 4.
Time frame: From initiation of analgesia to delivery
Total amount (mL) of local anesthetic administered during labor.
Time frame: First 30 minutes after epidural bolus
Changes in systolic/diastolic blood pressure and heart rate compared to baseline
Time frame: During labor until delivery
Incidence of hypotension, nausea, vomiting, pruritus, urinary retention, or other complications.
Time frame: Day 3 and Day 7 postpartum
Presence or absence of typical post-dural puncture headache symptoms.
Time frame: During labor until delivery
Any abnormal fetal heart rate patterns following neuraxial analgesia.
Time frame: From initiation of analgesia to delivery
Time in minutes or hours from epidural bolus administration to birth.
Time frame: At 1 minute and 5 minutes after birth
Neonatal Apgar scores assessed at 1 and 5 minutes postpartum.
Time frame: Immediately after delivery
Patient satisfaction with labor analgesia measured on a 0-10 Likert scale.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"
Acronym: DPE-LABOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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