Goal-directed Labor Epidural Analgesia Maintenance (GLEAM)

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Labor Onset and Length Abnormalities

Treatments: Other: CEI; Other: PIEB

Study type: Interventional

Funder types: Other

Identifiers

NCT05255263

GLEAM

Details and patient eligibility

About

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.

Full description

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

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Programmed Intermittent Epidural Bolus

Active Comparator group

Description:

Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion

Treatment:

Other: PIEB

Continuous Epidural Infusion

Active Comparator group

Description:

Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion

Treatment:

Other: CEI