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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Epidural Analgesia | Active Comparator | 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. |
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| Dural Puncture Epidural (DPE) Analgesia | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Epidural Analgesia | Procedure | Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Analgesic Consumption | Cumulative bupivacaine consumption measured in milligrams. | 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 | Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Effects | Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia | Continuously monitored from the initial epidural dose until delivery. |
| Requirement for Supplemental Analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38026464 | Background | Lin W, Yang Y, Lin J, Chen J, Lin Q. Dural Puncture Epidural with 25-G Spinal Needles versus Conventional Epidural Technique in Conjunction with PIEB for Labor Analgesia: A Randomized Trial. J Pain Res. 2023 Nov 8;16:3797-3805. doi: 10.2147/JPR.S424082. eCollection 2023. | |
| 32282386 | Background | Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768. |
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only IPD used in the results publication
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dural Puncture Epidural Analgesia | Procedure | Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by the same standardized dose of bupivacaine with fentanyl. |
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Total number of supplemental boluses required during labor
| From the initiation of epidural analgesia until delivery. |
| Maternal Satisfaction | Documented patient satisfaction levels regarding the childbirth experience | Assessed in the early postpartum period. |
| Post-Dural Puncture Headache | Incidence and severity of post-dural puncture headache in the postpartum period. | Up to 1 week postpartum. |
| Incidence and Severity of Motor Block | Occurrence and degree of motor block, evaluated by the Modified Bromage Scale. | 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. | Continuously monitored throughout the procedure. |
| 33545772 | Background | Wang J, Zhang L, Zheng L, Xiao P, Wang Y, Zhang L, Zhou M. A randomized trial of the dural puncture epidural technique combined with programmed intermittent epidural boluses for labor analgesia. Ann Palliat Med. 2021 Jan;10(1):404-414. doi: 10.21037/apm-20-2281. |