Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial
| Registry | NCT07349082 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 72 (Estimated) |
| Sponsor | Gadjah Mada University (Other) |
| Conditions | Cesarean Section |
| Interventions | Dural Puncture Epidural (DPE) Anesthesia, epidural anesthesia (Procedure) |
| Dates | start 2026-01-05 (estimated), primary completion 2026-04-01 (estimated), completion 2026-05-01 (estimated), first posted 2026-01-16, last updated 2026-01-16 |
| Locations | 2 sites in Indonesia |
Related Papers Related Patents Related Grants Related Experts
All trials for Cesarean Section All trials of Dural Puncture Epidural (DPE) Anesthesia All trials of epidural anesthesia
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dural Puncture Epidural (DPE) Anesthesia | Experimental | Procedure: Dural Puncture Epidural (DPE) Anesthesia | Participants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery. |
| Epidural Anesthesia | Active comparator | Procedure: epidural anesthesia | Participants receive a conventional epidural anesthesia for elective cesarean delivery. |
Sex: Female
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Dr. Sardjito General Hospital | Sleman, DI Yogyakarta | Indonesia | |
| Persahabatan General Hospital | Jakarta, DKI Jakarta | Indonesia |