Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

NCT03389945 | Completed

• 1 other identifier: 922/17
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Labor Pain; Epidural Analgesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Gestational age

  42 weeks

• Obstetric history

  At the time of recruitment

• Type of labor

  At the time of delivery

• Oxytocin dose

  At the time of DPE

• Cervical dilation

  At the time of DPE

Other Outcomes (1)

• Demographic data

  At the time of recruitment

Study Arms (2)

25G Dural Puncture Epidural Block

ACTIVE COMPARATOR

Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.

Procedure: 25G Dural Puncture Epidural Block

27G Dural Puncture Epidural Block

EXPERIMENTAL

Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.

Procedure: 27G Dural Puncture Epidural Block

Interventions

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.

25G Dural Puncture Epidural Block

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.

27G Dural Puncture Epidural Block

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pregnant woman
• singleton and vertex presentation
• weeks of gestational age
• active labor with cervical dilation \< 5cm
• body mass index between 20 and 35 kg/m2
• desired labor epidural analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Location

Hospital La Florida

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (8)

• 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.

  PMID: 8610864 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.

  PMID: 18931227 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.

  PMID: 28067707 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.

  PMID: 27035462 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.

  PMID: 16249679 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.

  PMID: 15321605 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.

  PMID: 9637643 BACKGROUND

• 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.

  PMID: 31118278 DERIVED

MeSH Terms

Conditions

Labor Pain; Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor, Department of Anesthesia

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 4, 2018
• Study Start: January 13, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 19, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)