Labor Pain
Conditions
Keywords
Analgesia, Epidural, Labor, Obstetric Analgesia, Obstetrical
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.
Interventions
OTHERCoordinate I
PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
OTHERCoordinate J
PIEB Next Bolus: 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
OTHERCoordinate K
PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
OTHERCoordinate L
PIEB Next Bolus: 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
OTHERCoordinate M
PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
OTHERCoordinate F
PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
OTHERCoordinate G
PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
OTHERCoordinate H
PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
OTHERCoordinate A
PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
OTHERCoordinate B
PIEB Next Bolus: 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
OTHERCoordinate C
PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
OTHERCoordinate D
PIEB Next Bolus: 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
OTHERCoordinate E
PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
OTHERCoordinate N
PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Sponsors
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
double-blind randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal satisfaction score | 24 hours following delivery | quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied |
| 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 |
| 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 |
Countries
Canada
Outcome results
None listed