Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

• ClinicalTrials.gov Identifier: NCT03389945
• Recruitment Status: Completed
• First Posted: January 4, 2018
• Last Update Posted: June 4, 2020
• Sponsor: University of Chile
• Information provided by (Responsible Party): Felipe Contreras Godoy, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Labor Pain; Epidural Analgesia	Procedure: 25G Dural Puncture Epidural Block; Procedure: 27G Dural Puncture Epidural Block	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.
• Actual Study Start Date: January 13, 2018
• Actual Primary Completion Date: March 12, 2019
• Actual Study Completion Date: March 19, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Time to pain ≤ 1 on NRS (0-10) [ Time Frame: 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 :

1. Gestational age [ Time Frame: 42 weeks ]
   Gestational age at the time of recruitment
2. Obstetric history [ Time Frame: At the time of recruitment ]
   Number of previous pregnancies and deliveries
3. Type of labor [ Time Frame: At the time of delivery ]
   Spontaneous versus induced labor
4. Oxytocin dose [ Time Frame: At the time of DPE ]
   Oxytocin infusion/dose at time of DPE
5. Cervical dilation [ Time Frame: At the time of DPE ]
   Cervical dilation at the time of DPE
6. State of membrane [ Time Frame: At the time of DPE ]
   Intact versus ruptured membrane at the time of DPE
7. Pre-DPE level of pain [ Time Frame: Immediate before DPE ]
   Evaluated with a NRS from 0 to 10
8. Amount of IV fluids [ Time Frame: 24 hours ]
   Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
9. Intervertebral level of puncture [ Time Frame: At the time of DPE ]
   Lumbar interspace where DPE was successfully performed
10. Number of DPE attempts [ Time Frame: 1 hour ]
    Number of attempts for successful DPE
11. Incidence of accidental dural puncture [ Time Frame: 1 hour ]
    Incidence of accidental dural puncture with the epidural Tuohy needle
12. Performance time [ Time Frame: 1 hour ]
    Temporal interval between skin disinfection and epidural catheter fixation to the skin
13. Sensory block height [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Sensory block height at 30 minutes after local anesthetic injection
14. Bilateral S2 sacral root block [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Measured every 2 minutes after local anesthetic injection
15. Presence of motor block [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Evaluated using a modified Bromage score
16. Number of epidural top-ups during labor [ Time Frame: After DPE up to delivery ]
    Number of extra doses of local anesthetic given after DPE up to delivery
17. Type of delivery [ Time Frame: Delivery ]
    Incidence of Cesarean section, normal delivery, and instrumented delivery
18. Incidence of epidural catheter adjustment or replacement [ Time Frame: After DPE up to delivery ]
    Necessity of adjustment or replacement of the epidural catheter
19. DPE side effects [ Time Frame: After DPE up to delivery ]
    Incidence of nausea, pruritus, hypotension
20. Fetal-Uterine assessment [ Time Frame: Before and up to 1 hour after DPE ]
    Frequency of contractions, uterine tonus, fetal heart rate tracing
21. Tocolysis requirement [ Time Frame: Up to 1 hour after DPE ]
    Necessity to administer a tocolytic agent after DPE
22. Apgar scores [ Time Frame: At 1 and 5 minutes after delivery ]
    Assessment of newborn condition
23. DPE complications [ Time Frame: After DPE up to 7 days postpartum ]
    Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
24. Epidural blood patch incidence [ Time Frame: Up to 1 week of followup ]
    Necessity of performing of a blood patch to relieve post dural puncture headache symptoms

Other Outcome Measures:

1. Demographic data [ Time Frame: At the time of recruitment ]
   Age, height, weight, BMI

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Chile

Hospital Clínico Universidad de Chile

Santiago, Metropolitana, Chile

Hospital La Florida

Santiago, Región Metropolitana, Chile

Sponsors and Collaborators

University of Chile

More Information

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Contreras F, Morales J, Bravo D, Layera S, Jara Á, Riaño 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. pii: rapm-2019-100608. doi: 10.1136/rapm-2019-100608. [Epub ahead of print]

• Responsible Party: Felipe Contreras Godoy, Clinical Instructor, Department of Anesthesia, University of Chile
• ClinicalTrials.gov Identifier: NCT03389945
• Other Study ID Numbers: 922/17
• First Posted: January 4, 2018
• Last Update Posted: June 4, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Contreras Godoy, University of Chile:

Labor analgesia; Dural puncture epidural; Postdural puncture headache; Neuraxial analgesia

Additional relevant MeSH terms:

Agnosia; Labor Pain; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain