Clinical trial NCT05255263: Goal-directed Labor Epidural Analgesia Maintenance
Official title: Programmed Intermittent Epidural Bolus vs. Continuous Epidural Infusion: a Multicenter, Pragmatic, Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Labor Onset and Length Abnormalities
Keywords: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, cluster-randomized, open-labeled, multiple-crossover trial
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Spontaneous Vaginal Delivery
timeFrame: Delivery
Secondary outcomes:
measure: Cesarean Delivery
timeFrame: Delivery
measure: Instrumental Vaginal Delivery
timeFrame: Delivery
measure: Length of Second Stage
timeFrame: During labor up to time of delivery
measure: Failed Epidural
timeFrame: During labor up to time of delivery
measure: Local anesthetic concentration
timeFrame: During labor up to time of delivery
measure: Epidural opioids used
timeFrame: During labor up to time of delivery
measure: Epidural opioids used
timeFrame: During labor up to time of delivery
measure: CEI rate
timeFrame: During labor up to time of delivery
measure: PIEB Volume
timeFrame: During labor up to time of delivery
measure: PIEB Interval
timeFrame: During labor up to time of delivery
measure: PCEA Volume
timeFrame: During labor up to time of delivery
measure: PCEA Lockout
timeFrame: During labor up to time of delivery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Mission Bay
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald B George, MD
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: Xu J, Zhou J, Xiao H, Pan S, Liu J, Shang Y, Yao S. A Systematic Review and Meta-Analysis Comparing Programmed Intermittent Bolus and Continuous Infusion as the Background Infusion for Parturient-Controlled Epidural Analgesia. Sci Rep. 2019 Feb 22;9(1):2583. doi: 10.1038/s41598-019-39248-5.
citation: Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.
citation: McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.
citation: Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.
citation: Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.