Clinical trial NCT02573597: PIEB vs CEI for Labor Analgesia: An MLAC Study
Official title: Programmed Intermittent Epidural Bolus (PIEB) Compared to Continuous Epidural Infusion (CEI) Relative Efficacy and Mechanism of Efficacy For Labor Anlagesia: A Minimal Local Analgesic Concentration (MLAC) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pregnancy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2015-10-12
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
timeFrame: From initial epidural bolus to delivery (up to approximately 16 hours)
Secondary outcomes:
measure: Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Numerical Verbal Pain Scores
timeFrame: Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Patient Satisfaction With Labor Analgesia
timeFrame: Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)
measure: Labor Outcome (Spontaneous, Assisted, Cesarean)
timeFrame: At the time of delivery
measure: Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Number of Participants With Maternal Nausea/Vomiting
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Protocol Success or Failure
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Other outcomes:
measure: Maternal Pruritis
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Motor Weakness
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Number and Total Dose of Clinician Rescue Boluses
timeFrame: From initial epidural bolus to approximately 6-12 hours following delivery
measure: Total CEI and PIEB Local Anesthetic and Opioid Use
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Requests to Turn Epidural Down or Stop Infusion.
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
measure: Duration of Epidural Analgesia
timeFrame: From initial epidural bolus to delivery (up to 16 hours following initial bolus)
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh, MDCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
citation: Ginosar Y, Columb MO, Cohen SE, Mirikatani E, Tingle MS, Ratner EF, Angst MS, Riley ET. The site of action of epidural fentanyl infusions in the presence of local anesthetics: a minimum local analgesic concentration infusion study in nulliparous labor. Anesth Analg. 2003 Nov;97(5):1439-1445. doi: 10.1213/01.ANE.0000081792.84877.A2.