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

• Sponsor: IWK Health Centre (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03871530
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 14
• Anticipated Duration (Months): 16.6
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Other: Coordinate A; Other: Coordinate B; Other: Coordinate C; Other: Coordinate D; Other: Coordinate E; Other: Coordinate F; Other: Coordinate G; Other: Coordinate H; Other: Coordinate I; Other: Coordinate J; Other: Coordinate K; Other: Coordinate L; Other: Coordinate M; Other: Coordinate N	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blind randomized trialdouble-blind randomized trial
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
• Actual Study Start Date: Apr 29, 2019
• Anticipated Primary Completion Date: Mar 15, 2020
• Anticipated Study Completion Date: Sep 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maternal satisfaction score [24 hours following delivery]

   quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied

2. Number of clinician administered rescue boluses [Start of labour epidural to delivery time]

   Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump

3. Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered [Start of labour epidural to delivery time]

   Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IWK Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8

Sponsors and Collaborators

• IWK Health Centre

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 22, 2019

More Information

Publications

None provided.

• Responsible Party: Allana, Principle Investigator, IWK Health Centre
• ClinicalTrials.gov Identifier: NCT03871530
• Other Study ID Numbers: 1023951
• First Posted: Mar 12, 2019
• Last Update Posted: Jun 14, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allana, Principle Investigator, IWK Health Centre: Analgesia; Epidural; Labor; Obstetric Analgesia; Obstetrical
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Jun 14, 2019