Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
- Conditions
- Epidural AnalgesiaLabor Pain
- Interventions
- Procedure: 25G Dural Puncture Epidural BlockProcedure: 27G Dural Puncture Epidural Block
- Registration Number
- NCT03389945
- Lead Sponsor
- University of Chile
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 25G Dural Puncture Epidural Block 25G Dural Puncture Epidural Block Patients will receive a dural puncture epidural block with a 25 gauge spinal needle. 27G Dural Puncture Epidural Block 27G Dural Puncture Epidural Block Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.
- Primary Outcome Measures
Name Time Method Time to pain ≤ 1 on NRS (0-10) Up to 30 minutes after local anesthetic injection Time elapsed between the end of local anesthetic injection and achievement of pain ≤ 1 on the NRS (measured every 2 minutes)
- Secondary Outcome Measures
Name Time Method Type of labor At the time of delivery Spontaneous versus induced labor
Number of DPE attempts 1 hour Number of attempts for successful DPE
Obstetric history At the time of recruitment Number of previous pregnancies and deliveries
Incidence of accidental dural puncture 1 hour Incidence of accidental dural puncture with the epidural Tuohy needle
Gestational age 42 weeks Gestational age at the time of recruitment
Oxytocin dose At the time of DPE Oxytocin infusion/dose at time of DPE
Bilateral S2 sacral root block Up to 30 minutes after local anesthetic injection Measured every 2 minutes after local anesthetic injection
Presence of motor block Up to 30 minutes after local anesthetic injection Evaluated using a modified Bromage score
Type of delivery Delivery Incidence of Cesarean section, normal delivery, and instrumented delivery
State of membrane At the time of DPE Intact versus ruptured membrane at the time of DPE
Intervertebral level of puncture At the time of DPE Lumbar interspace where DPE was successfully performed
Tocolysis requirement Up to 1 hour after DPE Necessity to administer a tocolytic agent after DPE
Apgar scores At 1 and 5 minutes after delivery Assessment of newborn condition
Epidural blood patch incidence Up to 1 week of followup Necessity of performing of a blood patch to relieve post dural puncture headache symptoms
Cervical dilation At the time of DPE Cervical dilation at the time of DPE
Pre-DPE level of pain Immediate before DPE Evaluated with a NRS from 0 to 10
Amount of IV fluids 24 hours Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
Performance time 1 hour Temporal interval between skin disinfection and epidural catheter fixation to the skin
Incidence of epidural catheter adjustment or replacement After DPE up to delivery Necessity of adjustment or replacement of the epidural catheter
DPE side effects After DPE up to delivery Incidence of nausea, pruritus, hypotension
DPE complications After DPE up to 7 days postpartum Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
Sensory block height Up to 30 minutes after local anesthetic injection Sensory block height at 30 minutes after local anesthetic injection
Number of epidural top-ups during labor After DPE up to delivery Number of extra doses of local anesthetic given after DPE up to delivery
Fetal-Uterine assessment Before and up to 1 hour after DPE Frequency of contractions, uterine tonus, fetal heart rate tracing
Trial Locations
- Locations (2)
Hospital Clínico Universidad de Chile
🇨🇱Santiago, Metropolitana, Chile
Hospital La Florida
🇨🇱Santiago, Región Metropolitana, Chile