Palo Alto, California 94305


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02573597


Primary Contact:

Principal Investigator
Brendan Carvalho, MBBCh, MDCH
Stanford University

Brendan Carvalho, MBBCh, MDCH
Phone: (650) 724-2614
Email: bcarvalho@stanford.edu


Backup Contact:

Email: edriley@stanford.edu
Ed Riley, MD
Phone: (650) 723-6411


Location Contact:

Palo Alto, California 94305
United States

Aramina Aksamit, RN
Phone: 512-287-0594
Email: aramina.a@gmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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