PIEB vs CEI for Labor Analgesia: An MLAC Study

Last updated: September 20, 2022
Sponsor: Stanford University
Overall Status: Terminated

Phase

4

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT02573597
34734
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 definedby chronic opiate consumption), Women who are participating in another study that willimpact protocol

Study Design

Total Participants: 31
Study Start date:
October 01, 2015
Estimated Completion Date:
May 22, 2018

Study 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.

Connect with a study center

  • Lucile Packard Children's Hospital

    Palo Alto, California 94305
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.