PIEB vs CEI for Labor Analgesia: An MLAC Study
- Registration Number
- NCT02573597
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 31
- 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
- <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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Group 1 Sufentanil CEI bupivacaine and CEI sufentanil Part A Group 2 Bupivacaine PIEB bupivacaine and PIEB sufentanil Part A Group 1 Bupivacaine CEI bupivacaine and CEI sufentanil Part A Group 2 Sufentanil PIEB bupivacaine and PIEB sufentanil Part B Group 3 Bupivacaine CEI bupivacaine and PIEB sufentanil Part B Group 3 Sufentanil CEI bupivacaine and PIEB sufentanil Part B Group 4 Sufentanil PIEB bupivacaine and CEI sufentanil Part B Group 4 Bupivacaine PIEB bupivacaine and CEI sufentanil
- Primary Outcome Measures
Name Time Method Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion From initial epidural bolus to delivery (up to approximately 16 hours) The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
- Secondary Outcome Measures
Name Time Method Protocol Success or Failure From initial epidural bolus to delivery (up to 16 hours following initial bolus) Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -\> 0.01% w/v reduction in subsequent participant's local anesthetic.
Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation -\>0.01% w/v increase in subsequent LA infusion.Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose) From initial epidural bolus to delivery (up to 16 hours following initial bolus) The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups.
Numerical Verbal Pain Scores Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus) The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups.
Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension From initial epidural bolus to delivery (up to 16 hours following initial bolus) Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported.
Number of Participants With Maternal Nausea/Vomiting From initial epidural bolus to delivery (up to 16 hours following initial bolus) yes/no.
Patient Satisfaction With Labor Analgesia Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours) 0-100% (0 means least satisfaction and 100 means most satisfaction)
Labor Outcome (Spontaneous, Assisted, Cesarean) At the time of delivery Labor outcome in patients who have success or failure outcome were compared between groups.
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States