Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dural Puncture Epidural (DPE) Anesthesia, epidural anesthesia.
- Who it may be relevant to
- Registry conditions: Cesarean Section. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial
Overview
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
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-resist - 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 administ
Primary outcome measures
- Time (minutes) to achieve bilateral T6 sensory block [Time frame: 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 [Time frame: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)]
Secondary outcome measures (6)
- Mean Arterial Pressure (MAP) [Time frame: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery]
- Heart Rate (HR) [Time frame: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery]
- Number of participants with Post-dural Puncture Headache (PDPH) [Time frame: Within 72 hours after neuraxial anesthesia]
- Number of participants with nausea and/or vomiting [Time frame: During anesthetic administration and surgery]
- APGAR Score [Time frame: At 1 and 5 minutes after birth]
- Number of participants with hypotension [Time frame: From anesthetic administration until the end of surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Indonesia · 2 centers
- Dr. Sardjito General Hospital — Sleman
- Persahabatan General Hospital — Jakarta
Identifiers
NCT: NCT07349082 · NaufalRCT1