Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

Study Overview
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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.

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

Conditions
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Labor Pain, Epidural Analgesia

Intervention / Treatment
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* Procedure: 25G Dural Puncture Epidural Block
* Procedure: 27G Dural Puncture Epidural Block


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25G Dural Puncture Epidural Block<br>Patients will receive a dural puncture epidural block with a 25 gauge spinal needle. | Procedure: 25G Dural Puncture Epidural Block<br>* 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.<br>|
| Experimental: 27G Dural Puncture Epidural Block<br>Patients will receive a dural puncture epidural block with a 27 gauge spinal needle. | Procedure: 27G Dural Puncture Epidural Block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 30 minutes after local anesthetic injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age | Gestational age at the time of recruitment | 42 weeks | 
| Obstetric history | Number of previous pregnancies and deliveries | At the time of recruitment | 
| Type of labor | Spontaneous versus induced labor | At the time of delivery | 
| Oxytocin dose | Oxytocin infusion/dose at time of DPE | At the time of DPE | 
| Cervical dilation | Cervical dilation at the time of DPE | At the time of DPE | 
| State of membrane | Intact versus ruptured membrane at the time of DPE | At the time of DPE | 
| Pre-DPE level of pain | Evaluated with a NRS from 0 to 10 | Immediate before DPE | 
| Amount of IV fluids | Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery) | 24 hours | 
| Intervertebral level of puncture | Lumbar interspace where DPE was successfully performed | At the time of DPE | 
| Number of DPE attempts | Number of attempts for successful DPE | 1 hour | 
| Incidence of accidental dural puncture | Incidence of accidental dural puncture with the epidural Tuohy needle | 1 hour | 
| Performance time | Temporal interval between skin disinfection and epidural catheter fixation to the skin | 1 hour | 
| Sensory block height | Sensory block height at 30 minutes after local anesthetic injection | Up to 30 minutes after local anesthetic injection | 
| Bilateral S2 sacral root block | Measured every 2 minutes after local anesthetic injection | Up to 30 minutes after local anesthetic injection | 
| Presence of motor block | Evaluated using a modified Bromage score | 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 | After DPE up to delivery | 
| Type of delivery | Incidence of Cesarean section, normal delivery, and instrumented delivery | Delivery | 
| Incidence of epidural catheter adjustment or replacement | Necessity of adjustment or replacement of the epidural catheter | After DPE up to delivery | 
| DPE side effects | Incidence of nausea, pruritus, hypotension | After DPE up to delivery | 
| Fetal-Uterine assessment | Frequency of contractions, uterine tonus, fetal heart rate tracing | Before and up to 1 hour after DPE | 
| Tocolysis requirement | Necessity to administer a tocolytic agent after DPE | Up to 1 hour after DPE | 
| Apgar scores | Assessment of newborn condition | At 1 and 5 minutes after delivery | 
| DPE complications | Incidence of post dural puncture headache, back pain, paresthesia and motor deficit | 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 | Up to 1 week of followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor analgesia, Dural puncture epidural, Postdural puncture headache, Neuraxial analgesia