AzTrials
AzTrials

Labor PainNCT03389945

Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

A study testing 25G Dural Puncture Epidural Block and 27G Dural Puncture Epidural Block in people with Labor Pain and Epidural Analgesia, run by University of Chile at 2 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Labor Pain, Epidural Analgesia
What is being tested?
25G Dural Puncture Epidural Block and 27G Dural Puncture Epidural Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesChile
Study dates
13 Jan 2018to 19 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Chile2 sites

  • Hospital Clínico Universidad de Chile

    Santiago, Santiago Metropolitan

  • Hospital La Florida

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: 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.

Being tested
25G Dural Puncture Epidural Block, 27G Dural Puncture Epidural Block
Keywords
Labor analgesia, Dural puncture epidural, Postdural puncture headache, Neuraxial analgesia
Medical subject headings
Labor Pain, Post-Dural Puncture Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 25G Dural Puncture Epidural BlockProcedure or surgery

    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.

  • 27G Dural Puncture Epidural BlockProcedure or surgery

    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.

Study groups in NCT03389945
Study groupRoleWhat they receive
25G Dural Puncture Epidural BlockActive comparatorPatients will receive a dural puncture epidural block with a 25 gauge spinal needle.
Receives: Procedure: 25G Dural Puncture Epidural Block
27G Dural Puncture Epidural BlockExperimentalPatients will receive a dural puncture epidural block with a 27 gauge spinal needle.
Receives: Procedure: 27G Dural Puncture Epidural Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 30 minutes after local anesthetic injection

Secondary outcomes (24)

  1. Gestational age

    Gestational age at the time of recruitment

    Measured: 42 weeks

  2. Obstetric history

    Number of previous pregnancies and deliveries

    Measured: At the time of recruitment

  3. Type of labor

    Spontaneous versus induced labor

    Measured: At the time of delivery

  4. Oxytocin dose

    Oxytocin infusion/dose at time of DPE

    Measured: At the time of DPE

  5. Cervical dilation

    Cervical dilation at the time of DPE

    Measured: At the time of DPE

  6. State of membrane

    Intact versus ruptured membrane at the time of DPE

    Measured: At the time of DPE

  7. Pre-DPE level of pain

    Evaluated with a NRS from 0 to 10

    Measured: Immediate before DPE

  8. Amount of IV fluids

    Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)

    Measured: 24 hours

  9. Intervertebral level of puncture

    Lumbar interspace where DPE was successfully performed

    Measured: At the time of DPE

  10. Number of DPE attempts

    Number of attempts for successful DPE

    Measured: 1 hour

  11. Incidence of accidental dural puncture

    Incidence of accidental dural puncture with the epidural Tuohy needle

    Measured: 1 hour

  12. Performance time

    Temporal interval between skin disinfection and epidural catheter fixation to the skin

    Measured: 1 hour

  13. Sensory block height

    Sensory block height at 30 minutes after local anesthetic injection

    Measured: Up to 30 minutes after local anesthetic injection

  14. Bilateral S2 sacral root block

    Measured every 2 minutes after local anesthetic injection

    Measured: Up to 30 minutes after local anesthetic injection

  15. Presence of motor block

    Evaluated using a modified Bromage score

    Measured: Up to 30 minutes after local anesthetic injection

  16. Number of epidural top-ups during labor

    Number of extra doses of local anesthetic given after DPE up to delivery

    Measured: After DPE up to delivery

  17. Type of delivery

    Incidence of Cesarean section, normal delivery, and instrumented delivery

    Measured: Delivery

  18. Incidence of epidural catheter adjustment or replacement

    Necessity of adjustment or replacement of the epidural catheter

    Measured: After DPE up to delivery

  19. DPE side effects

    Incidence of nausea, pruritus, hypotension

    Measured: After DPE up to delivery

  20. Fetal-Uterine assessment

    Frequency of contractions, uterine tonus, fetal heart rate tracing

    Measured: Before and up to 1 hour after DPE

  21. Tocolysis requirement

    Necessity to administer a tocolytic agent after DPE

    Measured: Up to 1 hour after DPE

  22. Apgar scores

    Assessment of newborn condition

    Measured: At 1 and 5 minutes after delivery

  23. DPE complications

    Incidence of post dural puncture headache, back pain, paresthesia and motor deficit

    Measured: After DPE up to 7 days postpartum

  24. Epidural blood patch incidence

    Necessity of performing of a blood patch to relieve post dural puncture headache symptoms

    Measured: Up to 1 week of followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start13 Jan 2018
  3. Primary completion12 Mar 2019
  4. Study completion19 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389945
Sponsor's protocol ID
922/17
Status last verified
Jun 2020
First submitted
14 Dec 2017
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 8610864

  • 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.

    PubMed 18931227

  • 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.

    PubMed 28067707

  • 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.

    PubMed 27035462

  • 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.

    PubMed 16249679

  • 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.

    PubMed 15321605

  • 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.

    PubMed 9637643

  • 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.

    PubMed 31118278

Questions about this trial

What is this clinical trial studying?

A study testing 25G Dural Puncture Epidural Block and 27G Dural Puncture Epidural Block in people with Labor Pain and Epidural Analgesia, run by University of Chile at 2 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to pain ≤ 1 on NRS (0-10) (time frame: Up to 30 minutes after local anesthetic injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389945, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in