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

NCT07349082 | Not Yet Recruiting

• 1 other identifier: NaufalRCT1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
3. 3.What procedure-related side effects occur with each anesthetic technique?
4. 4.Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
5. 5.Undergo elective cesarean delivery under regional anesthesia
6. 6.Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively

Conditions

Cesarean Section

Keywords

cesarean section; epidural anesthesia; dural puncture epidural; sensory block onset; hemodynamic stability

Outcome Measures

Primary Outcomes (2)

• Time (minutes) to achieve bilateral T6 sensory block

  Sensory block onset is defined as the time from anesthetic injection until the achievement of sensory block at the T6 dermatome on both the left and right sides. The measurement is recorded in minutes using a stopwatch.

  From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).

• Time (minutes) to achieve Bromage grade 3 motor block

  Motor block onset is defined as the time from anesthetic injection until the achievement of Bromage grade 3 motor block (inability to raise the straight leg). The measurement is recorded in minutes using a stopwatch.

  From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)

Secondary Outcomes (6)

• Mean Arterial Pressure (MAP)

  From baseline (minute 0) to 20 minutes after anesthetic administration during surgery

• Heart Rate (HR)

  From baseline (minute 0) to 20 minutes after anesthetic administration during surgery

• Number of participants with Post-dural Puncture Headache (PDPH)

  Within 72 hours after neuraxial anesthesia

• Number of participants with nausea and/or vomiting

  During anesthetic administration and surgery

• APGAR Score

  At 1 and 5 minutes after birth

Study Arms (2)

Dural Puncture Epidural (DPE) Anesthesia

EXPERIMENTAL

Participants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery.

Procedure: Dural Puncture Epidural (DPE) Anesthesia

Epidural Anesthesia

ACTIVE COMPARATOR

Participants receive a conventional epidural anesthesia for elective cesarean delivery.

Procedure: epidural anesthesia

Interventions

Dural Puncture Epidural (DPE) Anesthesia PROCEDURE

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.

Dural Puncture Epidural (DPE) Anesthesia

epidural anesthesia PROCEDURE

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%).

Epidural Anesthesia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women scheduled to undergo cesarean delivery
• American Society of Anesthesiologists (ASA) physical status II-III
• Willing to participate in the study by providing written informed consent

You may not qualify if:

• Patients with absolute contraindications to neuraxial anesthesia
• Patients with known allergy or history of allergy to medications used in the study
• Patients with psychiatric disorders or who are uncooperative
• Patients with accidental dural puncture
• Dropout Criteria:
• Patients who require conversion to general anesthesia during the procedure
• Patients who experience major intraoperative complications (massive hemorrhage, shock, or cardiac arrest)

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (2)

Dr. Sardjito General Hospital

Sleman, DI Yogyakarta, Indonesia

Location

Persahabatan General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Interventions

Anesthesia; Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anesthesia, Conduction

Central Study Contacts

Naufal Anasy, dr., Sp.An-TI

CONTACT

+62 813-4239-8761; naufal.anasy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 16, 2026
• Study Start: January 5, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ID (2)