Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Ronald B George, MD
Headshot of Ronald B George
Ronald B George

Description

Summary

The GLEAM trial is a multicenter, pragmatic, cluster-randomized trial to assess the effects of programmed intermittent epidural bolus versus continuous epidural infusion on the rate of spontaneous vaginal delivery and several other clinically-relevant outcomes.

Official Title

Programmed Intermittent Epidural Bolus vs. Continuous Epidural Infusion: a Multicenter, Pragmatic, Cluster-randomized Trial

Details

BACKGROUND: The goal of Labor Epidural Analgesia (LEA) to provide optimal analgesia while limiting any impact on the course of labor. Until recently, the most common technique for epidural analgesia was a combination of continuous epidural infusion (CEI) and patient controlled epidural analgesia (PCEA). CEI delivers an infusion of local anesthetic into the epidural space at a constant rate. Programmed intermittent epidural bolus (PIEB)-a more recently-developed alternative to CEI-delivers intermittent boluses of local anesthetic into the epidural space at scheduled time intervals. A series of randomized control trials (RCT) have compared PIEB and CEI with overall results favoring PIEB for superior analgesia. However, CEI has been shown to be associated with an increased amount of local anesthetic consumption, which may increase the degree of motor blockade, placing parturients at higher risk for instrumental and cesarean deliveries. Studies to date have offered conflicting conclusions on whether CEI is associated with a reduced rates of normal spontaneous vaginal delivery (NSVD). AIM: The GLEAM trial aims to investigate the hypothesis that PIEB will have higher rates of NSVD than CEI. The effects of CEI vs. PIEB on cesarean delivery rate, instrumental vaginal delivery rate, length of second stage of labor, failed epidural rate. TRIAL DESIGN: Multi-center, pragmatic, cluster-randomized trial - Centers will be assigned to use either PIEB or CEI for the first-line labor epidural analgesia maintenance infusion for clusters of minimum one month duration - Participating institutions will be recruited via the Society for Obstetric Anesthesia and Perinatology (SOAP) Research Network - Centers must use an epidural solution with a low concentration of local anesthesia with an opioid. - Both PIEB and CEI must include PCEA - rates and volumes are determined by the institution - Neuraxial anesthesia can be initiated with Dural Puncture Epidural (DPE), Combined Spinal Epidural (CSE) or epidural bolus - Our sample will consist of all women, at least 18 years of age, who were admitted to the labour & delivery ward for planned vaginal delivery and had neuraxial analgesia - Data will be collected in routine clinical care and automatically extracted from the electronic health record (EHR) PARTICIPATING SITE CRITERIA: - Routinely provided LEA with Ropivacaine ≤ 0.125% or Bupivacaine ≤ 0.1% epidural solutions with fentanyl (1-3 mcg/ml) - Can provide LEA with PIEB or CEI - Must include PCEA as part of all LEA regardless of PIEB or CEI

Keywords

Labor Onset and Length Abnormalities Cesarean Delivery Programmed Intermittent Epidural Bolus (PIEB) Continuous Epidural Infusion (CEI) Patient-Controlled Epidural Analgesia (PCEA) Normal Spontaneous Vaginal Delivery (NSVD) Instrumental Vaginal Delivery Second Stage of Labor Congenital Abnormalities PIEB CEI Programmed Intermittent Epidural Bolus Continuous Epidural Infusion

Eligibility

You can join if…

Open to females ages 18 years and up

  • Requests labor epidural analgesia requiring epidural maintenance with local anesthesia and opioid for planned vaginal delivery

You CAN'T join if...

  • Planned cesarean delivery
  • Planned operative vaginal delivery
  • Epidural time (placement to delivery) < 1 hour

Location

  • UCSF Mission Bay
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Ronald B George, MD
    Professor, Anesthesia, School of Medicine. Authored (or co-authored) 67 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05255263
Study Type
Interventional
Last Updated