A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

Labor Pain Clinical Trial

Official title:

A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871530
• Other study ID #: 1023951
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2022
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparous,
• English speaking
• 18-45 years
• single gestation = 37 weeks
• vertex presentation
• American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
• requesting an epidural for labour analgesia
• cervical dilation = 7 cm at the time of initiation of epidural analgesia.

Exclusion Criteria:

• Preeclampsia or HELLP syndrome
• maternal cardiac disease
• severe or uncontrolled maternal systemic disease
• contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
• abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
• chronic analgesic use
• a physical or psychiatric condition which may impair cooperation
• known fetal anomalies/intrauterine fetal demise
• height < 5'0"
• Body Mass Index > 45 kg/m2

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• Coordinate A
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
• Coordinate B
PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
• Coordinate C
PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
• Coordinate D
PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
• Coordinate E
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
• Coordinate F
PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
• Coordinate G
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
• Coordinate H
PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
• Coordinate I
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
• Coordinate J
PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
• Coordinate K
PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
• Coordinate L
PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
• Coordinate M
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
• Coordinate N
PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal satisfaction score	quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied	24 hours following delivery
Primary	Number of clinician administered rescue boluses	Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump	Start of labour epidural to delivery time
Primary	Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered	Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery	Start of labour epidural to delivery time