Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

University of Chile

Status

Completed

Conditions

Labor Pain

Epidural Analgesia

Treatments

Procedure: 27G Dural Puncture Epidural Block

Procedure: 25G Dural Puncture Epidural Block

Study type

Interventional

Funder types

Other

Identifiers

NCT03389945

922/17

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

healthy pregnant woman
singleton and vertex presentation
37-42 weeks of gestational age
active labor with cervical dilation < 5cm
body mass index between 20 and 35 kg/m2
desired labor epidural analgesia

Exclusion criteria

adults who are unable to give their own consent
presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
known fetal anomalies
increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
allergy to LA
prior sacral or lumbar spine surgery