Epidural Analgesia, Labor Pain
Conditions
Keywords
Labor analgesia, Dural puncture epidural, Postdural puncture headache, Neuraxial analgesia
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.
Interventions
PROCEDURE25G 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.
PROCEDURE27G 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.
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gestational age | 42 weeks | Gestational age at the time of recruitment |
| Obstetric history | At the time of recruitment | Number of previous pregnancies and deliveries |
| Type of labor | At the time of delivery | Spontaneous versus induced labor |
| Oxytocin dose | At the time of DPE | Oxytocin infusion/dose at time of DPE |
| Cervical dilation | At the time of DPE | Cervical dilation at the time of DPE |
| State of membrane | At the time of DPE | Intact versus ruptured membrane 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) |
| Intervertebral level of puncture | At the time of DPE | Lumbar interspace where DPE was successfully performed |
| Number of DPE attempts | 1 hour | Number of attempts for successful DPE |
| Performance time | 1 hour | Temporal interval between skin disinfection and epidural catheter fixation to the skin |
| Sensory block height | Up to 30 minutes after local anesthetic injection | Sensory block height at 30 minutes after local anesthetic injection |
| 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 |
| 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 |
| Type of delivery | Delivery | Incidence of Cesarean section, normal delivery, and instrumented delivery |
| Fetal-Uterine assessment | Before and up to 1 hour after DPE | Frequency of contractions, uterine tonus, fetal heart rate tracing |
| 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 |
| DPE complications | After DPE up to 7 days postpartum | Incidence of post dural puncture headache, back pain, paresthesia and motor deficit |
| Epidural blood patch incidence | Up to 1 week of followup | Necessity of performing of a blood patch to relieve post dural puncture headache symptoms |
| Incidence of accidental dural puncture | 1 hour | Incidence of accidental dural puncture with the epidural Tuohy needle |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic data | At the time of recruitment | Age, height, weight, BMI |
Countries
Chile
Outcome results
None listed