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Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

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ClinicalTrials.gov Identifier: NCT03389945
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Felipe Contreras Godoy, University of Chile

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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.





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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389945


Contacts
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Contact: Felipe Contreras, MD 229788221 felipeandrescontrerasgodoy@gmail.com
Contact: Daniela Bravo, MD 984276252 dbravoadvis@uchile.cl

Locations
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Chile
Hospital Clínico Universidad de Chile Recruiting
Santiago, Metropolitana, Chile
Contact: Felipe Contreras, MD    229788221    felipeandrescontrerasgodoy@gmail.com   
Contact: Daniela Bravo, MD    56984276252    dbravoadvis@uchile.cl   
Hospital La Florida Recruiting
Santiago, Región Metropolitana, Chile
Contact: Juan Morales, MD    978882913    jnmorale@gmail.com   
Contact: Natalia de la Fuente, MD    973870118    natalia.delafuente@gmail.com   
Sponsors and Collaborators
University of Chile

Publications:

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Responsible Party: Felipe Contreras Godoy, Clinical Instructor, Department of Anesthesia, University of Chile
ClinicalTrials.gov Identifier: NCT03389945     History of Changes
Other Study ID Numbers: 922/17
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Agnosia
Labor Pain
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pain