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DPE Technique in Labor Epidural for Morbidly Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074695
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Labor Pain Procedure: Dural puncture epidural (DPE) Procedure: Standard Epidural (EPL) Drug: Dural puncture epidural (DPE) Drug: Standard Epidural (EPL) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for Epidural Labor Analgesia: Comparison of Dural Puncture Epidural With Standard Labor Epidural Techniques
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dural Puncture Epidural (DPE)
Women who have analgesia initiated with a DPE technique
Procedure: Dural puncture epidural (DPE)
Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing

Drug: Dural puncture epidural (DPE)
Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.

Experimental: Standard Epidural (EPL)
Women who have analgesia initiated with an epidural technique
Procedure: Standard Epidural (EPL)
Standard epidural placement

Drug: Standard Epidural (EPL)
Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.




Primary Outcome Measures :
  1. Difference and change in analgesia [ Time Frame: From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours). ]
    Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery


Secondary Outcome Measures :
  1. Time to pain relief [ Time Frame: Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10 ]
    Time to numeric pain relief scale <= 1

  2. Motor block [ Time Frame: From time of randomization to time of baby delivery (estimated 72 hours) ]
    Degree of motor block

  3. Incidence of maternal adverse events [ Time Frame: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours) ]
    Hypotension, fetal bradycardia, post-dural puncture headache

  4. Duration of second stage of labor [ Time Frame: From time of randomization to time of baby delivery (estimated 72 hours) ]
    Duration of second stage of labor

  5. Total labor epidural time [ Time Frame: Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours) ]
    Total labor epidural time

  6. Total anesthetic dose required [ Time Frame: From time of randomization to time of baby delivery (estimated 72 hours) ]
    Including physician interventions, programmed doses, and patient controlled doses

  7. Mode of delivery [ Time Frame: From time of randomization to time of baby delivery (estimated 72 hours) ]
    Spontaneous, assisted, or cesarean delivery

  8. Change in subjective pain control [ Time Frame: From time of randomization, every 2 hours until time of delivery. (estimated 72 hours) ]
    Numeric pain rating scale


Other Outcome Measures:
  1. Satisfaction in anesthetic care - Likert scale [ Time Frame: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours) ]
    Maternal satisfaction with anesthetic care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT03074695


Contacts
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Contact: Jennifer Mehdiratta 9199234784 jennifer.mehdiratta@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: Jennifer E Lee, MD MPH         
Principal Investigator: Ashraf Habib         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashraf Habib Duke University Hospital Systems
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: Pro00079368

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03074695    
Other Study ID Numbers: Pro00079368
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Obesity, Morbid
Labor Pain
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pain
Neurologic Manifestations