Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor
1 other identifier
interventional
40
1 country
1
Brief Summary
Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with a pump that could only provide continuous infusion of the freezing medication in combination of pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this continuous infusion of medication is not as effective as previously thought, and suggested that instead of continuous infusion, intermittent programmed pushes should be used. The investigators now have devices that are able to do that. Programmed intermittent epidural bolus (PIEB) is a new technological advance based on the concept that boluses of freezing medication in the epidural space are superior to continuous epidural infusion (CEI). The new pumps are able to deliver bolus of medication at regular intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. Based on the information already available in the literature, this study aims to determine the best regimen of PIEB achievable with our standard epidural mixture. The hypothesis of this study is that there is an optimal interval time between PIEB boluses of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 3, 2016
May 1, 2016
3 months
September 2, 2015
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
No request for supplemental analgesia
No request for supplemental analgesia (PCEA bolus or clinician administered bolus) until the completion of the first stage of labor or until 6 hours following initiation of the programmed intermittent epidural bolus (PIEB).
6 hours
Secondary Outcomes (4)
Sensory block level
6 hours
Motor block level assessed using Bromage score
6 hours
Hypotension
6 hours
Pain score
6 hours
Study Arms (4)
60 minutes
EXPERIMENTALThe infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
50 minutes
EXPERIMENTALThe infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
40 minutes
EXPERIMENTALThe infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
30 minutes
EXPERIMENTALThe infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 10mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.0625% Bupivacaine plus fentanyl 2mcg/ml will also be available.
Interventions
0.0625% Bupivacaine plus fentanyl 2mcg/ml
Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
Eligibility Criteria
You may qualify if:
- ASA I or II
- Full term (≥ 37 weeks gestation)
- nulliparous
- Singleton pregnancy, vertex presentation
- Regular painful contractions occurring at least every 5 minutes
- VAS Pain score at requesting analgesia \> 5 (VNPS 0-10)
- Cervical dilatation \< 5 cm
You may not qualify if:
- Refusal to provide written informed consent.
- Any contraindication to epidural anesthesia
- Accidental dural puncture
- Allergy or hypersensitivity to bupivacaine or fentanyl
- Use of opioids or sedatives within the last 4 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose CA Carvalho, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 15, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 3, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share