PIEB vs CEI for Labor Analgesia: An MLAC Study

Stanford University

Status and phase: Terminated; Phase 4

Conditions: Pregnancy

Treatments: Drug: Sufentanil; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02573597

34734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 4 patient groups

Part A Group 1

Active Comparator group

Description:

CEI bupivacaine and CEI sufentanil

Treatment:

Drug: Sufentanil

Drug: Bupivacaine

Part A Group 2

Active Comparator group

Description:

PIEB bupivacaine and PIEB sufentanil

Treatment:

Drug: Sufentanil

Drug: Bupivacaine

Part B Group 3

Active Comparator group

Description:

CEI bupivacaine and PIEB sufentanil

Treatment:

Drug: Sufentanil

Drug: Bupivacaine

Part B Group 4

Active Comparator group

Description:

PIEB bupivacaine and CEI sufentanil

Treatment:

Drug: Sufentanil

Drug: Bupivacaine