Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

University of Chile140 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

140

Conditions

Labor Pain Epidural Analgesia

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (2)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Hospital La Florida

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

Time to pain ≤ 1 on NRS (0-10)

Time elapsed between the end of local anesthetic injection and achievement of pain ≤ 1 on the NRS (measured every 2 minutes)

Time frame: Up to 30 minutes after local anesthetic injection

Secondary Outcomes

Gestational age

Gestational age at the time of recruitment

Time frame: 42 weeks

Obstetric history

Number of previous pregnancies and deliveries

Time frame: At the time of recruitment

Type of labor

Spontaneous versus induced labor

Time frame: At the time of delivery

Oxytocin dose

Oxytocin infusion/dose at time of DPE

Time frame: At the time of DPE

Cervical dilation

Cervical dilation at the time of DPE

Time frame: At the time of DPE

State of membrane

Intact versus ruptured membrane at the time of DPE

Time frame: At the time of DPE

Pre-DPE level of pain

Evaluated with a NRS from 0 to 10

Time frame: Immediate before DPE

Amount of IV fluids

Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)

Time frame: 24 hours

Intervertebral level of puncture

Lumbar interspace where DPE was successfully performed

Time frame: At the time of DPE

Number of DPE attempts

Number of attempts for successful DPE

Time frame: 1 hour

Incidence of accidental dural puncture

Incidence of accidental dural puncture with the epidural Tuohy needle

Time frame: 1 hour

Performance time

Temporal interval between skin disinfection and epidural catheter fixation to the skin

Time frame: 1 hour

Sensory block height

Sensory block height at 30 minutes after local anesthetic injection

Time frame: Up to 30 minutes after local anesthetic injection

Bilateral S2 sacral root block

Measured every 2 minutes after local anesthetic injection

Time frame: Up to 30 minutes after local anesthetic injection

Presence of motor block

Evaluated using a modified Bromage score

Time frame: Up to 30 minutes after local anesthetic injection

Number of epidural top-ups during labor

Number of extra doses of local anesthetic given after DPE up to delivery

Time frame: After DPE up to delivery

Type of delivery

Incidence of Cesarean section, normal delivery, and instrumented delivery

Time frame: Delivery

Incidence of epidural catheter adjustment or replacement

Necessity of adjustment or replacement of the epidural catheter

Time frame: After DPE up to delivery

DPE side effects

Incidence of nausea, pruritus, hypotension

Time frame: After DPE up to delivery

Fetal-Uterine assessment

Frequency of contractions, uterine tonus, fetal heart rate tracing

Time frame: Before and up to 1 hour after DPE

Tocolysis requirement

Necessity to administer a tocolytic agent after DPE

Time frame: Up to 1 hour after DPE

Apgar scores

Assessment of newborn condition

Time frame: At 1 and 5 minutes after delivery

DPE complications

Incidence of post dural puncture headache, back pain, paresthesia and motor deficit

Time frame: After DPE up to 7 days postpartum

Epidural blood patch incidence

Necessity of performing of a blood patch to relieve post dural puncture headache symptoms

Time frame: Up to 1 week of followup