Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Epidural Anesthesia: Epidural catheter placed with an 18G epidural needle without dural puncture; anesthesia established with the study epidural drug mixture.

Dural Puncture Epidural With 27G Spinal Needle: Needle-through-needle dural puncture with a 27G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture.

Dural Puncture Epidural With 26G Spinal Needle: Needle-through-needle dural puncture with a 26G spinal needle via an 18G epidural needle, followed by epidural catheter placement without intrathecal drug; anesthesia established with the study epidural drug mixture.

Study summary

The goal of this clinical trial is to learn whether the dural puncture epidural (DPE) technique shortens the onset time of surgical anesthesia compared with the standard epidural technique in healthy women undergoing elective cesarean delivery, and whether the size of the spinal needle used for dural puncture (27-gauge vs 26-gauge pencil point) changes this effect.

The main question it aims to answer is: Does DPE with a 27G or 26G spinal needle reduce the time from completion of epidural drug injection to bilateral T5 sensory block compared with standard epidural anesthesia?

Researchers will also compare hypotension, ephedrine use, need for additional epidural local anesthetic, motor block, sensory block regression, and post-dural puncture headache among the three groups.

Participants will be randomly assigned to one of three groups: standard epidural, DPE with a 27G spinal needle, or DPE with a 26G spinal needle. In all groups, the same epidural drug mixture will be given through the epidural catheter, and no drug will be injected into the cerebrospinal fluid. Sensory block will be tested every minute after injection, and headache will be checked at 24 and 48 hours after surgery.

Eligibility

Primary outcome measure(s)

• Onset time of surgical anesthesia — From t0 up to 20 minutes
  Time (minutes) from completion of epidural drug injection (t0) to bilateral loss of pinprick sensation at the T5 dermatome, assessed every minute.

Trial sites (1)

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