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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

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE January 13, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03389945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
  • Gestational age [ Time Frame: 42 weeks ]
    Gestational age at the time of recruitment
  • Obstetric history [ Time Frame: At the time of recruitment ]
    Number of previous pregnancies and deliveries
  • Type of labor [ Time Frame: At the time of delivery ]
    Spontaneous versus induced labor
  • Oxytocin dose [ Time Frame: At the time of DPE ]
    Oxytocin infusion/dose at time of DPE
  • Cervical dilation [ Time Frame: At the time of DPE ]
    Cervical dilation at the time of DPE
  • State of membrane [ Time Frame: At the time of DPE ]
    Intact versus ruptured membrane at the time of DPE
  • Pre-DPE level of pain [ Time Frame: Immediate before DPE ]
    Evaluated with a NRS from 0 to 10
  • Amount of IV fluids [ Time Frame: 24 hours ]
    Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)
  • Intervertebral level of puncture [ Time Frame: At the time of DPE ]
    Lumbar interspace where DPE was successfully performed
  • Number of DPE attempts [ Time Frame: 1 hour ]
    Number of attempts for successful DPE
  • Incidence of accidental dural puncture [ Time Frame: 1 hour ]
    Incidence of accidental dural puncture with the epidural Tuohy needle
  • Performance time [ Time Frame: 1 hour ]
    Temporal interval between skin disinfection and epidural catheter fixation to the skin
  • Sensory block height [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Sensory block height at 30 minutes after local anesthetic injection
  • Bilateral S2 sacral root block [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Measured every 2 minutes after local anesthetic injection
  • Presence of motor block [ Time Frame: Up to 30 minutes after local anesthetic injection ]
    Evaluated using a modified Bromage score
  • 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
  • Type of delivery [ Time Frame: Delivery ]
    Incidence of Cesarean section, normal delivery, and instrumented delivery
  • Incidence of epidural catheter adjustment or replacement [ Time Frame: After DPE up to delivery ]
    Necessity of adjustment or replacement of the epidural catheter
  • DPE side effects [ Time Frame: After DPE up to delivery ]
    Incidence of nausea, pruritus, hypotension
  • Fetal-Uterine assessment [ Time Frame: Before and up to 1 hour after DPE ]
    Frequency of contractions, uterine tonus, fetal heart rate tracing
  • Tocolysis requirement [ Time Frame: Up to 1 hour after DPE ]
    Necessity to administer a tocolytic agent after DPE
  • Apgar scores [ Time Frame: At 1 and 5 minutes after delivery ]
    Assessment of newborn condition
  • DPE complications [ Time Frame: After DPE up to 7 days postpartum ]
    Incidence of post dural puncture headache, back pain, paresthesia and motor deficit
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 26, 2017)
Demographic data [ Time Frame: At the time of recruitment ]
Age, height, weight, BMI
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
Official Title  ICMJE Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Labor Pain
  • Epidural Analgesia
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • Active Comparator: 25G Dural Puncture Epidural Block
    Patients will receive a dural puncture epidural block with a 25 gauge spinal needle.
    Intervention: Procedure: 25G Dural Puncture Epidural Block
  • Experimental: 27G Dural Puncture Epidural Block
    Patients will receive a dural puncture epidural block with a 27 gauge spinal needle.
    Intervention: Procedure: 27G Dural Puncture Epidural Block
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2017)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Felipe Contreras, MD 229788221 felipeandrescontrerasgodoy@gmail.com
Contact: Daniela Bravo, MD 984276252 dbravoadvis@uchile.cl
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389945
Other Study ID Numbers  ICMJE 922/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Felipe Contreras Godoy, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP