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PIEB vs CEI for Labor Analgesia: An MLAC Study

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ClinicalTrials.gov Identifier: NCT02573597
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University

Brief Summary:
Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Bupivacaine Drug: Sufentanil Phase 4

Detailed Description:

Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.

Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.

Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.

Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.

DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study
Actual Study Start Date : October 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Part A Group 1
CEI bupivacaine and CEI sufentanil
Drug: Bupivacaine
Continuous or bolus administration
Other Name: marcaine

Drug: Sufentanil
Continuous or bolus administration
Other Name: sufenta

Active Comparator: Part A Group 2
PIEB bupivacaine and PIEB sufentanil
Drug: Bupivacaine
Continuous or bolus administration
Other Name: marcaine

Drug: Sufentanil
Continuous or bolus administration
Other Name: sufenta

Active Comparator: Part B Group 3
CEI bupivacaine and PIEB sufentanil
Drug: Bupivacaine
Continuous or bolus administration
Other Name: marcaine

Drug: Sufentanil
Continuous or bolus administration
Other Name: sufenta

Active Comparator: Part B Group 4
PIEB bupivacaine and CEI sufentanil
Drug: Bupivacaine
Continuous or bolus administration
Other Name: marcaine

Drug: Sufentanil
Continuous or bolus administration
Other Name: sufenta




Primary Outcome Measures :
  1. MLAC of the final participants in each respective group at study completion [ Time Frame: approximately 6-12 hours ]

Secondary Outcome Measures :
  1. Time to first clinician rescue analgesia request (from initial epidural dose) [ Time Frame: approximately 6-12 hours ]
  2. Numerical verbal pain scores [ Time Frame: approximately 6-12 hours ]
  3. Patient satisfaction with labor analgesia [ Time Frame: approximately 6-12 hours ]
    0-100%

  4. Duration of epidural analgesia [ Time Frame: approximately 6-12 hours ]
  5. Labor outcome (spontaneous, assisted, cesarean) [ Time Frame: approximately 6-12 hours ]
  6. Requests to turn epidural down or stop infusion. [ Time Frame: approximately 6-12 hours ]
    yes/no

  7. Total CEI and PIEB local anesthetic and opioid use [ Time Frame: approximately 6-12 hours ]
  8. Number and total dose of clinician rescue boluses [ Time Frame: approximately 6-12 hours ]
  9. Motor weakness [ Time Frame: approximately 6-12 hours ]
    Straight leg lift, yes/no

  10. Maternal pruritis [ Time Frame: approximately 6-12 hours ]
    scale from from 0-10

  11. Treatment for pruritus, nausea and vomiting, and hypotension [ Time Frame: approximately 6-12 hours ]
    yes/no

  12. Maternal nausea/vomiting [ Time Frame: 6-12 hours ]
    yes/no



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I & II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age

Exclusion Criteria:

  • <37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol

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): NCT02573597


Contacts
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Contact: Brendan Carvalho, MBBCh, MDCH (650) 724-2614 bcarvalho@stanford.edu
Contact: Ed Riley, MD (650) 723-6411 edriley@stanford.edu

Locations
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United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Aramina Aksamit, RN    512-287-0594    aramina.a@gmail.com   
Sponsors and Collaborators
Stanford University
Manchester University NHS Foundation Trust
Investigators
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Principal Investigator: Brendan Carvalho, MBBCh, MDCH Stanford University
Publications:
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Responsible Party: Brendan Carvalho, Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02573597    
Other Study ID Numbers: 34734
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Sufentanil
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General