CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
25G Dural Puncture Epidural Block +1 moreprocedure
Likely dose
25G Dural Puncture Epidural Blockfrom record
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Search/NCT03389945
NCT03389945N/ACompleted

Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.

University of Chile·interventional·Posted Jan 4, 2018·Updated Jun 4, 2020

In Brief

A clinical study evaluating 25G Dural Puncture Epidural Block and 27G Dural Puncture Epidural Block for Labor Pain and Epidural Analgesia. Completed, enrolled 140 participants across 2 sites.

Detailed Summary

The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia. Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle. In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartJan 13, 2018
Primary CompletionMar 12, 2019
Study CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.5 years ago

Interventions

25G Dural Puncture Epidural Blockprocedure

Dural puncture epidural analgesia using a 25G pencil point spinal needle at a lumbar interspace. Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.

27G Dural Puncture Epidural Blockprocedure

Dural puncture epidural analgesia using a 27G pencil point spinal needle at a lumbar interspace. Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.