Goal-directed Labor Epidural Analgesia Maintenance

Not Applicable

Withdrawn

• Conditions: Labor Onset and Length Abnormalities
• Interventions: Other: PIEB; Other: CEI

• Registration Number: NCT05255263
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-24
• Study Start: 2022-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Programmed Intermittent Epidural Bolus	PIEB	Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion
Continuous Epidural Infusion	CEI	Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion

Primary Outcome Measures

Name	Time	Method
Spontaneous Vaginal Delivery	Delivery	Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)

Secondary Outcome Measures

Name	Time	Method
Epidural opioids used	During labor up to time of delivery	Epidural opioid concentration (µg/mL)
CEI rate	During labor up to time of delivery	Continuous Epidural Infusion Rate (mL/hr)
PIEB Interval	During labor up to time of delivery	Programmed Intermittent Epidural Bolus (minutes)
PCEA Volume	During labor up to time of delivery	Patient-Controlled Epidural Analgesia bolus volume (mL)
PCEA Lockout	During labor up to time of delivery	Patient-Controlled Epidural Analgesia lockout time (minutes)
PIEB Volume	During labor up to time of delivery	Programmed Intermittent Epidural Bolus Volume (mL)
Cesarean Delivery	Delivery	Rate of Cesarean Delivery (Percent of total deliveries)
Instrumental Vaginal Delivery	Delivery	Rate of Instrumental Vaginal Delivery (Percent of total deliveries)
Length of Second Stage	During labor up to time of delivery	Length of Second Stage of Labor (hours)
Failed Epidural	During labor up to time of delivery	Rate of Failed Epidural, requiring general anesthesia or epidural replacement. (Percent of total labor epidural anesthetics)
Local anesthetic concentration	During labor up to time of delivery	Local anesthetic concentration (Percent solution)

Trial Locations

Locations (1)

UCSF Mission Bay; 🇺🇸 San Francisco, California, United States