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Dural Puncture Epidural Technique During Cesarean Section

NCT06184425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-05-20

No results posted yet for this study

Summary

DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.

Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal \&fetal complications.

Conditions

  • Anesthesia, Obstetric

Interventions

PROCEDURE

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

\- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 25-gauge pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.

PROCEDURE

Dural Puncture Epidural technique using pencil-point 27G Whitacre needle

\- DPE technique was performed in the sitting position at the L3/4 or L4/5 interspace via the midline approach using a 17-gauge Touhy needle and a loss of resistance to saline technique, then the dura was punctured with a 27-gauage pencil point Whitacre spinal needles using a needle-through-needle technique, and spontaneous flow of cerebrospinal fluid was confirmed, then the spinal needle was removed and a flexible 19-gauge, spring closed-tip catheter was inserted 5 cm into the epidural space toward the cranial side.

Sponsors & Collaborators

  • Reham Ali Abdelhaleem Abdelrahman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-11-06
Completion
2023-12-08

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184425 on ClinicalTrials.gov