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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dural Puncture Epidural (DPE) Anesthesia | Experimental | Participants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery. |
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| Epidural Anesthesia | Active Comparator | Participants receive a conventional epidural anesthesia for elective cesarean delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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until cerebrospinal fluid (CSF) is observed, indicating a micro-dural lesion, after which the spinal needle is withdrawn.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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (MAP) | Mean arterial pressure (MAP) is defined as the average arterial blood pressure during a single cardiac cycle and is monitored non-invasively using an automated blood pressure monitor. This parameter is recorded at baseline (minute 0) and subsequently measured every 3 minutes during the first 20 minutes following anesthetic administration. | From baseline (minute 0) to 20 minutes after anesthetic administration during surgery |
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Inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naufal Anasy, dr., Sp.An-TI | Contact | +62 813-4239-8761 | naufal.anasy@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sardjito General Hospital | Sleman | DI Yogyakarta | Indonesia | |||
| Persahabatan General Hospital |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
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| 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%). |
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| Heart Rate (HR) | Heart rate is defined as the number of heartbeats per minute and is measured automatically via standard patient monitoring. Heart rate is recorded at baseline (minute 0) and subsequently measured every 3 minutes during the first 20 minutes following anesthetic administration. | From baseline (minute 0) to 20 minutes after anesthetic administration during surgery |
| Number of participants with Post-dural Puncture Headache (PDPH) | Post-dural puncture headache (PDPH) is assessed as part of the side effect evaluation. PDPH is defined as a postural headache that worsens when the patient is sitting or standing and improves in the supine position, occurring within 48-72 hours after dural penetration. PDPH is evaluated as a secondary outcome as a potential complication following neuraxial anesthesia, including epidural and dural puncture epidural (DPE) techniques. | Within 72 hours after neuraxial anesthesia |
| Number of participants with nausea and/or vomiting | Nausea and vomiting are assessed as part of the side effect evaluation. These outcomes are defined as subjective complaints of nausea and/or observed episodes of vomiting occurring during anesthetic administration and throughout the cesarean delivery procedure. Events are assessed through direct observation and patient self-reporting. | During anesthetic administration and surgery |
| APGAR Score | APGAR Score is assessed as part of the side effect evaluation. Neonatal outcome is assessed using the Apgar score at 1 and 5 minutes after birth. The Apgar score evaluates five parameters: skin color, heart rate, reflex irritability, muscle tone, and respiration, with a total score ranging from 0 to 10. Apgar scores are recorded by trained healthcare personnel and used as an indicator of immediate neonatal clinical condition. | At 1 and 5 minutes after birth |
| Number of participants with hypotension | Hypotension is assessed as part of the side effect evaluation and defined as a decrease in blood pressure of ≥20% from baseline or a mean arterial pressure (MAP) <65 mmHg following neuraxial anesthesia. | From anesthetic administration until the end of surgery |
| Jakarta |
| DKI Jakarta |
| Indonesia |