NCT03389945

Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain
• Epidural Analgesia

Interventions

Type	Name	Description
PROCEDURE	25G Dural Puncture Epidural Block	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.
PROCEDURE	27G Dural Puncture Epidural Block	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.

Timeline

• Start date: 2018-01-13
• Primary completion: 2019-03-12
• Completion: 2019-03-19
• First posted: 2018-01-04
• Last updated: 2020-06-04

Locations

2 sites across 1 country: Chile