An observational study in Labor Pain and Epidural Analgesia, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Medipol University · Observational
Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction
The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS \< 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction. Note on outcome reporting: serial intrapartum measurements of maternal blood pressure, maternal heart rate and fetal heart rate were not documented on the routine anesthesia monitoring forms used during the retrospective control period. The registered secondary outcome of maternal hemodynamic and fetal heart rate variation could therefore not be compared between the two cohorts. Baseline values recorded before the procedure were available for all 100 participants and are reported as baseline characteristics, together with the incidence of hypotension and of fetal bradycardia. No registered outcome has been removed from this record.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 100 is close to the median of 101 across 56 observational studies indexed under Labor Pain.
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The study population consists of healthy pregnant women (ASA physical status I-II) with a singleton pregnancy at 37-42 weeks of gestation, who planned a vaginal delivery and requested labor analgesia during active labor (cervical dilation ≥ 4 cm) at a single university hospital.
Exclusion Criteria:
Patients in this retrospective control group received the standard concentration epidural analgesia. Using an 18-G Tuohy needle, the epidural space was identified and a catheter was advanced. No dural puncture was performed. A loading dose consisting of 0.125% bupivacaine (25 mg) and fentanyl (40 µg) in a total volume of 20 mL was administered via the catheter.
Procedure: Standard Epidural Analgesia
Patients in this prospective intervention group received the low-dose DPE technique. After identifying the epidural space, the dura mater was punctured using a 27-G spinal needle until the clear return of cerebrospinal fluid was visualized. No intrathecal medication was administered, the spinal needle was withdrawn, and the epidural catheter was positioned. A loading dose consisting of 0.0625% bupivacaine (12.5 mg) and fentanyl (40 µg) in a total volume of 20 mL was applied.
Procedure: Dural Puncture Epidural Analgesia
Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.
Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by administration of a lower concentration of bupivacaine with the same dose of fentanyl.
Total Analgesic Consumption
Cumulative bupivacaine consumption measured in milligrams.
Time frame: From the initiation of epidural analgesia until delivery.
Adequate Analgesia Achievement
Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4
Time frame: Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery.
Incidence of Adverse Effects
Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia
Time frame: Continuously monitored from the initial epidural dose until delivery.
Requirement for Supplemental Analgesia
Total number of supplemental boluses required during labor
Time frame: From the initiation of epidural analgesia until delivery.
Maternal Satisfaction
Documented patient satisfaction levels regarding the childbirth experience
Time frame: Assessed in the early postpartum period.
Post-Dural Puncture Headache
Incidence and severity of post-dural puncture headache in the postpartum period.
Time frame: Up to 1 week postpartum.
Incidence and Severity of Motor Block
Occurrence and degree of motor block, evaluated by the Modified Bromage Scale.
Time frame: Monitored throughout the procedure until delivery.
Maternal Hemodynamic and Fetal Heart Rate Variations
Variation in maternal blood pressure, heart rate, and fetal heart rate changes.
Time frame: Continuously monitored throughout the procedure.
Plan to share: Yes — only IPD used in the results publication
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