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Completed

NCT Number: NCT03915574

Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery

This study will compare two anesthetics techniques called Dural Puncture Epidural (DPE) and Standard Epidural as to which of the two can provide faster and potentially better at providing pain relief for cesarean sections. It will also compare these two anesthetics techniques on the percentage of women who require additional drugs to control pain during their cesarean deliveries. The results of this study will help anesthesiologists know which anesthetic technique can provide faster and potentially better at providing pain relief for cesarean sections.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72204, United States

About this study

The aim of this study is to compare the onset time of anesthesia between standard epidural and Dural Puncture Epidural (DPE) for cesarean delivery. The study will hypothesize that a DPE technique with a 25-gauge spinal needle will have a faster onset and improved quality of surgical anesthesia when compared to a standard epidural. Participants will be blinded to which group they are being assigned. An unblinded anesthesiologist will insert the epidural or DPE based on randomization. After insertion of the epidural or DPE, a low dose local anesthetic infusion will be infused into the epidural catheter up until the time of surgery. This is the standard infusion used to provide pain relief in laboring women (bupivacaine 0.0625% with 2 mcg/ml fentanyl). In this way participants enrolled in the study would mimic anesthetic the conditions of a "labor epidural".

Participants will then move on to the next phase of the study. In this phase, the epidural pump will be discontinued, and anesthesia care will be conducted in the same manner as all cesarean deliveries under epidural extension anesthesia (this refers to the process of providing anesthesia using a pre-existing epidural/DPE that was inserted for the purpose of providing labor analgesia). Anesthesia will be induced in a standardized manner with 20 ml of 3% chloroprocaine. Motor and sensory block will be tested at the end of the epidural loading dose. Loss of sharp sensation will be measured using a blunt plastic neurotip® (Owen Mumford, USA) until a sensory bilateral block to the T6 dermatomal level has been reached. The T6 level measured at the xiphoid process will be marked bilaterally with a washable marker pen to guarantee the precision of the primary endpoint (which will be assumed when sensory block goes above T6). Sensory testing will be performed from caudad to cephalad (i.e. from blocked to unblocked dermatomes) to identify the first unblocked dermatome. To identify the level where the sensation of touch is first appreciated, the investigator will ask the question: "Tell me when you feel the sensation of something sharp touching your skin." Both the motor and sensory block evaluations are part of the standard clinical care of patients receiving neuraxial anesthesia. The main difference for participants enrolled in the study is that the frequency of sensory assessments will be increased so that the onset of surgical anesthesia can be accurately documented (approximately every minute and then more frequently as the sensory block approaches the primary endpoints). A second anesthesiologist, blind to the type of block will manage the clinical care of the patient from the beginning of the study (after epidural catheter placement) and will administer the induction drug (prepared by that anesthesiologist as per SOC). There will be no difference in this clinician's care of the subject than if she were not enrolled in the study. This will assess the onset of anesthesia and manage all aspects of the subject's clinical care including the documentation of the local anesthetic (LA) solution administration timing and its clinical effects. The speed of onset will be assessed from the end of epidural test dose. This will be defined as time zero and the start of anesthesia. If required, intra-operative analgesia will be offered in the form of further epidural top-up, intravenous fentanyl, ketamine, nitrous oxide or replacement of neuraxial anesthesia/conversion into general anesthesia as the standard of care (SOC).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Singleton pregnancy
  • Gestation > 36 weeks
  • ASA class II and III
  • Provides written consent
  • Infant of mother
  • Elective or non-urgent cesarean delivery

Exclusion criteria

  • Patient refusal
  • Urgent/emergent cesarean sections
  • ASA and IV or above
  • Unable to understand English
  • Significant back surgery or scoliosis
  • Lethal fetal abnormality or likely to affect APGAR scores
  • Weight > 120 kg
  • Height < 150 cm
  • Allergy to study solutions

Treatment and study plan

25G Dural Puncture Epidural

Device

Dural puncture created with a 25 gauge spinal needle

Standard Epidural

Device

Control group - standard epidural (no dural puncture)

Primary outcomes

  1. Onset Time of Surgical Anesthesia

    Time frame: 2 hours

    The primary outcome will be the onset time of surgical anesthesia in seconds. This will be measured from the induction of anesthesia (as defined by the beginning of injection of the "Induction 1 syringe") to the point at which sharp sensation is lost bilaterally at the T6 dermatomal level (as measured by a blunt plastic neurotip® (Owen Mumford, USA) device)

Secondary outcomes

  1. Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia

    Time frame: 2 hours

    A composite outcome defined by failure to achieve at least a T10 bilateral sensory level pre-operatively (after 3 ml 1.5% lidocaine with 1:200,000 epinephrine 45 mg lidocaine and up to 20 ml of 0.0625% bupivacaine with 2mcg/ml fentanyl), the requirement for intraoperative analgesia supplementation, conversion to general anesthesia or repeat neuraxial procedure, or failure to achieve the primary outcome within 15 minutes between the two groups. Analyzed as a collapsed composite (any or none)

Other outcomes

  1. Maximum Pain During Surgery (Score)

    Time frame: 2 hours

    Maximum pain visual analogue scale during surgery (units on a scale, 0 - 10)

  2. Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery

    Time frame: 2 hours

    Vasopressor requirements during surgery required to maintain systolic blood pressure within 15% of baseline

  3. Patient Satisfaction With Anesthetic Technique (Score)

    Time frame: 4 hours

    Overall patient satisfaction score (units on a scale, 0 - 10)

  4. Neonatal Requirement for Resuscitation

    Time frame: 2 hours

    Neonatal Apgar scores (units on a scale, 0 - 10)

  5. Neonatal Physiological Condition

    Time frame: 2 hours

    Umbilical cord blood gases (pH measurement)

  6. Requirement for Opioids in the First 24 Hours After Surgery

    Time frame: 24 hours

    Opioid consumption measured in milligrams.

  7. Anesthesia Side Effects

    Time frame: 2 hours

    nausea, vomiting, itching (yes/no)

  8. Vasopressor Requirements During Surgery

    Time frame: 2 hours

    measured in milligrams

  9. Bromage Score (0 - 3 Scale)

    Time frame: 3 hours

    Motor block assessment 0 - Able to move hip, knee, and ankle

    • - unable to move hip, but able to move knee and ankle
    • - unable to move hip and knee, but able to move ankle
    • - unable to move hip, knee and ankle
  10. Sensory Block Assessment

    Time frame: 3 hours

    Assessed using sharp sensation at the midclavicular line on the abdomen and thorax Reported at the dermatomal level where sharp sensation is first felt

  11. Anesthesia Adverse Effects

    Time frame: 24 hours

    Accidental dural puncture, local anesthesia systemic toxicity, high spinal, post dural puncture headache

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery: A Randomized, Double-blind Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Dec 1, 2023

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.