Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section

Summary

The goal of this clinical trial is to compare the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing elective cesarean delivery. The study also aims to evaluate hemodynamic stability and procedure-related side effects associated with both techniques.

The main questions it aims to answer are:

1. What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section?
2. Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
3. What procedure-related side effects occur with each anesthetic technique?

Researchers will compare epidural anesthesia with dural puncture epidural (DPE) to determine which technique achieves a faster and more effective sensory block while maintaining maternal hemodynamic stability.

Participants will:

1. Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
2. Undergo elective cesarean delivery under regional anesthesia
3. Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively

Conditions

• Cesarean Section

Interventions

PROCEDURE

Dural Puncture Epidural (DPE) Anesthesia

Dural puncture epidural (DPE) is a combined neuraxial technique that integrates spinal and epidural approaches to enhance the quality of sensory and motor blockade. The procedure begins with dural puncture using a 26-gauge Spinocan spinal needle at the L3-L4 lumbar interspace until cerebrospinal fluid (CSF) is observed, indicating a micro-dural lesion, after which the spinal needle is withdrawn. Subsequently, an epidural catheter is inserted using an 18-gauge Tuohy needle with the loss-of-resistance (LOR) technique using saline, and advanced 4-5 cm into the epidural space. The anesthetic agents administered are the same as those used in conventional epidural anesthesia. This DPE technique is operationalized to accelerate sensory block onset, improve motor block quality, and minimize complications compared with conventional epidural anesthesia.

PROCEDURE

epidural anesthesia

Conventional epidural technique for elective cesarean delivery. Epidural anesthesia is a neuraxial technique used for analgesia or anesthesia during cesarean delivery by administering local anesthetic agents through a catheter placed in the epidural space without penetrating the dura mater. In this study, epidural anesthesia is operationalized by inserting an 18-gauge Tuohy needle at the L3-L4 lumbar interspace, advancing the epidural catheter 4-5 cm into the epidural space, followed by administration of 0.5% isobaric bupivacaine combined with 50 µg fentanyl. Parameters recorded include sensory and motor block onset, mean arterial pressure (MAP), heart rate, and procedure- and surgery-related adverse events. In this study, epidural anesthetic dosing is adjusted for patients with very short stature (height \<150 cm), with dose reduction based on published literature (10-20%).

Sponsors & Collaborators

• Gadjah Mada University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-05

Primary Completion

2026-04-01

Completion

2026-05-01

Countries

• Indonesia

Study Locations