Epidural vs. Dural Puncture Epidural in Labor Analgesia

Medipol University

Status: Completed

Conditions: Labor Pain; Epidural Analgesia

Treatments: Procedure: Standard Epidural Analgesia; Procedure: Dural Puncture Epidural Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06849726

Epidural vs DP epidural

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status I-II
• Gestational age 37-42 weeks
• Planned vaginal delivery
• Request for labor analgesia during active labor with cervical dilation ≥ 3-4 cm

Exclusion criteria

• Multiple gestations
• Diagnosis of preeclampsia/eclampsia
• Severe systemic disease
• Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site)
• History of opioid dependence
• Refusal to participate in the study protocol
• Missing data in medical records for the retrospective group

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Epidural Analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Epidural Analgesia

Dural Puncture Epidural (DPE) Analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Dural Puncture Epidural Analgesia