Goal-directed Labor Epidural Analgesia Maintenance

Labor Onset and Length Abnormalities Clinical Trial

— GLEAM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05255263
• Other study ID #: GLEAM
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Labor Onset and Length Abnormalities

Intervention

Other:
• PIEB
Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia
• CEI
Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia

Locations

Country	Name	City	State
United States	UCSF Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous Vaginal Delivery	Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)	Delivery
Secondary	Cesarean Delivery	Rate of Cesarean Delivery (Percent of total deliveries)	Delivery
Secondary	Instrumental Vaginal Delivery	Rate of Instrumental Vaginal Delivery (Percent of total deliveries)	Delivery
Secondary	Length of Second Stage	Length of Second Stage of Labor (hours)	During labor up to time of delivery
Secondary	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
Secondary	Local anesthetic concentration	Local anesthetic concentration (Percent solution)	During labor up to time of delivery
Secondary	Epidural opioids used	Epidural opioid (identity of opioid)	During labor up to time of delivery
Secondary	Epidural opioids used	Epidural opioid concentration (µg/mL)	During labor up to time of delivery
Secondary	CEI rate	Continuous Epidural Infusion Rate (mL/hr)	During labor up to time of delivery
Secondary	PIEB Volume	Programmed Intermittent Epidural Bolus Volume (mL)	During labor up to time of delivery
Secondary	PIEB Interval	Programmed Intermittent Epidural Bolus (minutes)	During labor up to time of delivery
Secondary	PCEA Volume	Patient-Controlled Epidural Analgesia bolus volume (mL)	During labor up to time of delivery
Secondary	PCEA Lockout	Patient-Controlled Epidural Analgesia lockout time (minutes)	During labor up to time of delivery