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A Randomized Comparative Study Between 25-Gauge and 27-Gauage Pencil Point Spinal Needles During Dural Puncture Epidural Anaesthesia For Elective Caesarean Section
Sponsor study identifier
interventional
110
1 country
1
Study Start
January 10, 2023
Actual (reported)Primary Completion
November 6, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)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of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2023
Actual (reported)November 6, 2023
Actual (reported)December 8, 2023
Actual (reported)December 14, 2023
Actual (reported)December 28, 2023
Actual (reported)was the onset time to surgical anesthesia
was defined as the time from the end of the intraoperative epidural test dose injection \[the start of epidural extension anaesthesia (time zero on the stopwatch)\] to when the sensory block level reached the T6 dermatome bilaterally (when the patient could no longer feel sharp sensation at T6) (assessed bilaterally at the midclavicular line)
up to 20 minutes after local anesthetic injection
\- 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.
Reham Ali Abdelhaleem Abdelrahman
Cairo, 11562, Egypt
110 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2023
First Posted
December 28, 2023
Study Start
January 10, 2023
Actual (reported)\- 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.
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Primary Completion
November 6, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)Last Updated
May 20, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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