Goal-directed Labor Epidural Analgesia Maintenance

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Labor Onset and Length Abnormalities

Intervention / Treatment
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* Other: PIEB
* Other: CEI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, cluster-randomized, open-labeled, multiple-crossover trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Programmed Intermittent Epidural Bolus<br>Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion | Other: PIEB<br>* Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia<br>|
| Active Comparator: Continuous Epidural Infusion<br>Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion | Other: CEI<br>* Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Vaginal Delivery | Rate of Spontaneous Vaginal Delivery (Percent of total deliveries) | Delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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