Cesarean SectionNCT07349082
Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section
A study testing Dural Puncture Epidural (DPE) Anesthesia and epidural anesthesia in people with Cesarean Section, run by Gadjah Mada University at 2 sites in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Dural Puncture Epidural (DPE) Anesthesia and epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesIndonesia
- Study dates
- 5 Jan 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites
Persahabatan General Hospital
Jakarta, DKI Jakarta
Dr. Sardjito General Hospital
Sleman, DI Yogyakarta
About this study
Official title: Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled 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:
Read more
- What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section?
- Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
- 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:
- Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
- Undergo elective cesarean delivery under regional anesthesia
- Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively
- Conditions
- Cesarean Section
- Being tested
- Dural Puncture Epidural (DPE) Anesthesia, epidural anesthesia
- Keywords
- cesarean section, epidural anesthesia, dural puncture epidural, sensory block onset, hemodynamic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural (DPE) AnesthesiaProcedure or surgery
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.
epidural anesthesiaProcedure or surgery
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%).
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural (DPE) Anesthesia | Experimental | Participants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery. Receives: Procedure: Dural Puncture Epidural (DPE) Anesthesia |
| Epidural Anesthesia | Active comparator | Participants receive a conventional epidural anesthesia for elective cesarean delivery. Receives: Procedure: epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)
Secondary outcomes (6)
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.
Measured: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From anesthetic administration until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naufal Anasy, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349082
- Sponsor's protocol ID
- NaufalRCT1
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349082
- Acronym / sponsor ID
- NaufalRCT1
- Conditions
- Cesarean Section
- Keywords
- cesarean section, epidural anesthesia, dural puncture epidural, sensory block onset, hemodynamic stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section?
- Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery?
- 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:
- Be randomly assigned to receive either epidural anesthesia or DPE anesthesia
- Undergo elective cesarean delivery under regional anesthesia
- Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural (DPE) Anesthesia | Experimental | Procedure: Dural Puncture Epidural (DPE) AnesthesiaParticipants receive a dural puncture epidural (DPE) anesthesia for elective cesarean delivery. |
| Epidural Anesthesia | Active comparator | Procedure: epidural anesthesiaParticipants receive a conventional epidural anesthesia for elective cesarean delivery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Patients who require conversion to general anesthesia during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dural Puncture Epidural (DPE) AnesthesiaDural 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. | Procedure or surgery | Dural Puncture Epidural (DPE) Anesthesia |
| epidural anesthesiaConventional 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%). | Procedure or surgery | Epidural Anesthesia |
Primary outcome
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).
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 (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)
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural Puncture Epidural (DPE) Anesthesia and epidural anesthesia in people with Cesarean Section, run by Gadjah Mada University at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naufal Anasy, dr., Sp.An-TI (+62 813-4239-8761, naufal.anasy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.