Comparison of Dural Puncture Epidural and Standard Epidural Anesthesia Techniques in Elective Cesarean Deliveries
NCT07295080 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-12-19
Summary
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.
Conditions
- Regional Anaesthesia in Cesarean Operations
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Ankara City Hospital Bilkent
lead OTHER
Principal Investigators
-
esra uyar turkyilmaz · Ankara City Hospital Bilkent
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-05-01
- Completion
- 2026-05-01
Countries
- Turkey (Türkiye)
Study Locations
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