DPE Technique in Labor Epidural for Morbidly Obese Women
Condition: Morbid Obesity; Labor Pain
MeSH terms: Obesity, Morbid; Labor Pain
Intervention: Dural puncture epidural (DPE); Standard Epidural (EPL); Dural puncture epidural (DPE); Standard Epidural (EPL)
Intervention description: Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing; Standard epidural placement; Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.; Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 141.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to determine differences in block quality between the
      "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in
      the morbidly obese patient. The investigators hypothesize that when compared to the standard
      EPL, the DPE technique will improve block quality .

      Study participants will be randomized by computer-generated sequence to EPL or DPE arms,
      stratified by class of obesity (BMI 35-39.9 kg/m2, 40< 50 kg/m2 and ≥ 50 kg/m2) and by parity
      (nulliparous versus multiparous). All patients will receive a neuraxial technique in the
      sitting position at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g
      Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will
      be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1%
      with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading
      dose and epidural pump is started, the blinded investigator will enter the patient's room to
      start data collection (time 0). Data will be collected for the first 30 minutes of epidural
      placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤
      1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain
      will be managed by a standardized protocol. Other data to be collected will include: catheter
      adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block,
      sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.

      The primary outcome of this study is block quality defined by a composite of five components:
      (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter
      adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring
      general anesthesia or replacement neuraxial anesthesia for emergency cesarean section.
      Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events
      (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total
      labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.

      There is no increased risk/safety issue with placing a dural puncture technique than with
      epidural for labor analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women admitted to the Duke Birthing Center for spontaneous or induced vaginal delivery
             will be screened. After usual consultation with the anesthesia team is completed and
             consent for anesthesia services are obtained, eligible patients will be approached to
             by a member of the study team.

          -  ages 18-45

          -  singleton

          -  vertex fetuses at 37-41 weeks' gestation

          -  nulliparous and multiparous women

          -  cervical dilation of 2-7cm

          -  BMI ≥ 35 kg/m2,

          -  pain score > 4

          -  English-speaking ability.

        Exclusion Criteria:

          -  chronic opioid use

          -  Major cardiac disease

          -  contraindications to regional anesthesia