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

Gadjah Mada University

Status: Not yet enrolling

Conditions: Cesarean Section

Treatments: Procedure: epidural anesthesia; Procedure: Dural Puncture Epidural (DPE) Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07349082

NaufalRCT1

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Dural Puncture Epidural (DPE) Anesthesia

Experimental group

Description:

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

Treatment:

Procedure: Dural Puncture Epidural (DPE) Anesthesia

Epidural Anesthesia

Active Comparator group

Description:

Participants receive a conventional epidural anesthesia for elective cesarean delivery.

Treatment:

Procedure: epidural anesthesia