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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25G Dural Puncture Epidural Block | Active Comparator | Patients will receive a dural puncture epidural block with a 25 gauge spinal needle. |
|
| 27G Dural Puncture Epidural Block | Experimental | Patients will receive a dural puncture epidural block with a 27 gauge spinal needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25G Dural Puncture Epidural Block | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age | Gestational age at the time of recruitment | 42 weeks |
| Obstetric history | Number of previous pregnancies and deliveries |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | Age, height, weight, BMI | At the time of recruitment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | Santiago Metropolitan | Chile | |||
| Hospital La Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8610864 | Background | Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028. | |
| 18931227 | Background | Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 27G Dural Puncture Epidural Block | 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. |
|
| 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 |
| Santiago |
| Santiago Metropolitan |
| Chile |
| 28067707 | Background | Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798. |
| 27035462 | Background | Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394. |
| 16249679 | Background | Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019. |
| 15321605 | Background | Landau R, Ciliberto CF, Goodman SR, Kim-Lo SH, Smiley RM. Complications with 25-gauge and 27-gauge Whitacre needles during combined spinal-epidural analgesia in labor. Int J Obstet Anesth. 2001 Jul;10(3):168-71. doi: 10.1054/ijoa.2000.0834. |
| 9637643 | Background | Beilin Y, Zahn J, Bernstein HH, Zucker-Pinchoff B, Zenzen WJ, Andres LA. Treatment of incomplete analgesia after placement of an epidural catheter and administration of local anesthetic for women in labor. Anesthesiology. 1998 Jun;88(6):1502-6. doi: 10.1097/00000542-199806000-00013. |
| 31118278 | Derived | Contreras F, Morales J, Bravo D, Layera S, Jara A, Riano C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ. Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Anesth Pain Med. 2019 May 22:rapm-2019-100608. doi: 10.1136/rapm-2019-100608. Online ahead of print. |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |