Comparison of Dural Puncture Epidural and Standard Epidural Anesthesia Techniques in Elective Cesarean Deliveries

Neuraxial techniques are the most effective form of labor analgesia in contemporary obstetric anesthesia practice, predominantly through the use of epidural (EPL) and combined spinal-epidural (CSE) techniques. Although drug combinations employed in these methods have advanced, the onset time, block quality, and side effect profiles of both techniques still require further improvement.

The epidural technique is associated with minimal side effects; however, it may occasionally present variable block characteristics such as slow onset, inadequate sacral spread, unilateral or patchy sensory block, motor impairment, and epidural catheter failure.

The dural puncture epidural (DPE) technique is performed by inserting a spinal needle through the shaft of the epidural needle to create a single dural perforation, after which an epidural catheter is placed into the epidural space without administering any drugs into the cerebrospinal fluid (CSF). All medications for analgesia or anesthesia are delivered into the epidural space via the catheter. The dural puncture is thought to provide a conduit that facilitates the translocation of drugs from the epidural space into the subarachnoid space, which is believed to account for the clinical features observed with the dural puncture epidural technique advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.

The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.

Compared with the epidural technique, the dural puncture epidural approach has been shown to improve the onset of sacral block as well as the spread of anesthesia and analgesia-characteristics that are particularly advantageous in obstetric patients. Additionally, the process of dural puncture with a spinal needle through the epidural needle allows cerebrospinal fluid return to serve as a "confirmatory" definitive endpoint for the position of the epidural needle tip within the epidural space.

The investigators designed this study to determine whether the dural puncture epidural technique, compared with epidural, could improve the onset time and block characteristics of anesthesia in elective cesarean deliveries.

Study Overview

• Status: Not yet recruiting
• Conditions: Regional Anaesthesia in Cesarean Operations
• Intervention / Treatment: Other: Dural puncture epidural (DPE) anaesthesia; Other: standart epidural anesthesia

Detailed Description

This study aims to evaluate the effects of dural puncture epidural (DPE) versus standard epidural anesthesia on the time to surgical anesthesia onset in patients scheduled for elective cesarean section.

• Study Population:

Pregnant women undergoing elective cesarean section

• Compared Techniques:

Dural Puncture Epidural Group → A dural puncture will be performed with a 27G spinal needle before the placement of the epidural catheter.

Standard Epidural Group → An epidural catheter will be placed directly without dural puncture.

• Primary Outcome:

Time from anesthesia administration to onset of surgical anesthesia (defined as time to achieve sensory block at the T5 dermatome level).

• Secondary Outcomes:

Incidence of hypotension

Intraoperative ephedrine requirement

Need for additional doses

Post-dural puncture headache (PDPH)

Time to regression of sensory block

Motor block assessment (Bromage scale)

Study Design:

Prospective: Patients will be identified before anesthesia administration and evaluated going forward.

Randomized: Patients will be randomly assigned to either the dural ponksiyon epidural or standard epidural group.

Controlled: The two groups will be compared to analyze the effects.

Single-Center: The study will be conducted at a single hospital. Inclusion Criteria

• Women scheduled for elective cesarean delivery
• No comorbidities
• Age between 18-40 years
• Body mass index (BMI) < 35 kg/m²
• Term pregnancy ≥ 37 weeks
• No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)

Parameters to Be Assessed

All parameters will be assessed by the investigator both intraoperatively and postoperatively in the ward. These include:

• Sensory block level (evaluated every minute as a study-specific parameter)
• Blood pressure
• Heart rate
• Oxygen saturation
• Requirement for ephedrine
• Requirement for additional epidural doses
• Incidence of post-dural puncture headache (at 24 and 48 hours)
• Motor block assessment (using the Bromage Scale)

Note: All evaluated parameters are part of standard monitoring, with the exception that sensory block level will be specifically assessed every minute for the purposes of this study.

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Exclusion Criteria

• Contraindications to neuraxial anesthesia
• Refusal to participate in the study

Withdrawal and Termination Criteria

• Patient's decision to withdraw from the study
• Conversion to general anesthesia
• Administration of intrathecal and/or intravenous drugs

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ozlem bayrak; Phone Number: +903125526000 +905558487653; Email: ozzlembayrak@gmail.com
• Study Contact Backup: Name: esra uyar türkyılmaz; Phone Number: +905053840429; Email: esrauyarturkyilmaz@yahoo.com

Study Locations

• Turkey (Türkiye)
  • çankaya
    • Ankara, çankaya, Turkey (Türkiye)
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women scheduled for elective cesarean delivery

  • No comorbidities
  • Age between 18-40 years
  • Body mass index (BMI) < 35 kg/m²
  • Term pregnancy ≥ 37 weeks
  • No contraindications to neuraxial anesthesia (e.g., coagulopathy, infection, history of prior spinal surgery, etc.)

Exclusion Criteria:

• Contraindications to neuraxial anesthesia

  • Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dural puncture epidural; The epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia.	Other: Dural puncture epidural (DPE) anaesthesia; The epidural space will be accessed using an 18G epidural needle, followed by dural puncture with a 27G spinal needle. Without administering any drug into the cerebrospinal fluid (CSF), an epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals.
Active Comparator: standart epidural anesthesia; The epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals. At the completion of the injection (t0), the patient will be placed in the supine position with a 10-degree left tilt. Sensory block level will be assessed every minute using the pinprick test. Bilateral sensory block at the T5 dermatome will be accepted as adequate surgical anaesthesia.	Other: standart epidural anesthesia; The epidural space will be accessed using an 18G epidural needle. An epidural catheter will then be inserted, through which anesthesia will be administered.Its placement will be confirmed with a test dose of 2 ml of 2% lidocaine. Following the test dose (after excluding signs of intrathecal or intravenous injection), a mixture consisting of 7.5 ml of 2% prilocaine, 7.5 ml of 0.5% bupivacaine, and 100 µg of fentanyl (2 ml) will be administered in 5-ml increments at 3-minute intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset time of sensory block	The time from the administration of anesthesia to the onset of surgical anesthesia (the time it takes for the sensory block to reach the Thoracic 5 (T5) dermatome).	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	a 20% reduction from baseline blood pressure	perioperative
intraoperative ephedrine requirement	total intraoperative ephedrine dose	perioperative
requirement for supplementery dosing	Failure to achieve sensory block at the Torakal 5 (T5) level within 20 minutes or the occurrence of perioperative pain	perioperative
Postdural puncture headache (PDPH)	Postoperative headaches will be evaluated at the 24th and 48th hours using the Visual Analog Scale (VAS)	day 2
Time to the onset of sensory block regression	The duration of sensory block regression from the Thoracic 5 (T5) to the Thoracic 10 (T10) and Lumbar 1 (L1) dermatomal levels	day 1
Assessment of motor block	The degree of motor block will be assessed using the Bromage score	day 1

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: esra uyar turkyilmaz, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
• Horcajada JP, Martinez JA, Moreno-Martinez A, Mensa J, Almela M, Soriano E. [Predictive factors of the presence of bacteremia in males with urinary infection]. Med Clin (Barc). 1999 May 29;112(19):734-5. Spanish.
• Tarraga P, Garcia-Olmo D, Celada A, Garcia-Molinero Mf, Divison JA, Casado C. Colorectal cancer screening through detection of fecal occult blood in a controlled health zone. Rev Esp Enferm Dig. 1999 May;91(5):335-44. English, Spanish.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: epidural anesthesia; dural puncture epidural anesthesia
• Additional Relevant MeSH Terms: Anesthesia and Analgesia; Anesthesia
• Other Study ID Numbers: 1251153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No