PIEB vs CEI for Labor Analgesia: An MLAC Study

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.

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