Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section
ConditionCesarean Section
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorGadjah Mada University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dural Puncture Epidural (DPE) Anesthesia
Procedure/SurgeryDural 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until cerebrospinal fluid (CSF) is observed, indicating a micro-dural lesion, after which the spinal needle is withdrawn.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.
epidural anesthesia
Procedure/SurgeryConventional 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%).
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Dural Puncture Epidural (DPE) AnesthesiaExperimental treatment 1 intervention
Group B: Epidural AnesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).2
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.
Time frame
From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)Secondary outcomes
1
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.
Time frame
From baseline (minute 0) to 20 minutes after anesthetic administration during surgery2
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.
Time frame
From baseline (minute 0) to 20 minutes after anesthetic administration during surgery3
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.
Time frame
Within 72 hours after neuraxial anesthesia4
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.
Time frame
During anesthetic administration and surgerySponsors and contacts
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Source ClinicalTrials.gov
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