Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-13

Study Completion Date

2019-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor Pain Epidural Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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25G Dural Puncture Epidural Block

Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.

Group Type ACTIVE_COMPARATOR

25G Dural Puncture Epidural Block

Intervention Type PROCEDURE

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 Block

Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.

Group Type EXPERIMENTAL

27G Dural Puncture Epidural Block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No