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Completed

NCT Number: NCT03389945

Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

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.

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Key information

Conditions

Labor Pain Brain Diseases Central Nervous System Diseases Epidural Analgesia Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile, Santiago, Santiago Metropolitan, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Demographic data

    Time frame: At the time of recruitment

    Age, height, weight, BMI

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2018
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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