Clinical trial NCT03389945: Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
Official title: Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Epidural Analgesia
Keywords: Labor analgesia
Dural puncture epidural
Postdural puncture headache
Neuraxial analgesia
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to pain ≤ 1 on NRS (0-10)
timeFrame: Up to 30 minutes after local anesthetic injection
Secondary outcomes:
measure: Gestational age
timeFrame: 42 weeks
measure: Obstetric history
timeFrame: At the time of recruitment
measure: Type of labor
timeFrame: At the time of delivery
measure: Oxytocin dose
timeFrame: At the time of DPE
measure: Cervical dilation
timeFrame: At the time of DPE
measure: State of membrane
timeFrame: At the time of DPE
measure: Pre-DPE level of pain
timeFrame: Immediate before DPE
measure: Amount of IV fluids
timeFrame: 24 hours
measure: Intervertebral level of puncture
timeFrame: At the time of DPE
measure: Number of DPE attempts
timeFrame: 1 hour
measure: Incidence of accidental dural puncture
timeFrame: 1 hour
measure: Performance time
timeFrame: 1 hour
measure: Sensory block height
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Bilateral S2 sacral root block
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Presence of motor block
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Number of epidural top-ups during labor
timeFrame: After DPE up to delivery
measure: Type of delivery
timeFrame: Delivery
measure: Incidence of epidural catheter adjustment or replacement
timeFrame: After DPE up to delivery
measure: DPE side effects
timeFrame: After DPE up to delivery
measure: Fetal-Uterine assessment
timeFrame: Before and up to 1 hour after DPE
measure: Tocolysis requirement
timeFrame: Up to 1 hour after DPE
measure: Apgar scores
timeFrame: At 1 and 5 minutes after delivery
measure: DPE complications
timeFrame: After DPE up to 7 days postpartum
measure: Epidural blood patch incidence
timeFrame: Up to 1 week of followup
Other outcomes:
measure: Demographic data
timeFrame: At the time of recruitment
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital La Florida
state: Región Metropolitana
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.