Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Labor Pain
• Intervention / Treatment: Procedure: 25G Dural Puncture Epidural Block; Procedure: 27G Dural Puncture Epidural Block

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Hospital Clínico Universidad de Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Hospital La Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 25G Dural Puncture Epidural Block; Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.	Procedure: 25G 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.
EXPERIMENTAL: 27G Dural Puncture Epidural Block; Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.	Procedure: 27G 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Age, height, weight, BMI	At the time of recruitment

Collaborators and Investigators

• Sponsor: University of Chile

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2018
• Primary Completion (ACTUAL): March 12, 2019
• Study Completion (ACTUAL): March 19, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Labor analgesia; Postdural puncture headache; Dural puncture epidural; Neuraxial analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Labor Pain; Agnosia
• Other Study ID Numbers: 922/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No