NCT02758405

Brief Summary

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 investigators are currently using pumps set up with PIEB, in addition to what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption. The investigators have recently concluded a study at MSH using PIEB where they observed excellent results. However, some patients exhibited higher than necessary sensory blocks. The investigators believe that the technique can be optimized by using the same dose of the freezing medication, but using a smaller volume of local anesthetic at a higher concentration. This optimization may also further reduce the amount of medication used by each patient. 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 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml that will provide women the necessary drug requirements, thus avoiding breakthrough pain and need for PCEA or physician intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

April 29, 2016

Last Update Submit

May 23, 2017

Conditions

Labor Pain

Keywords

EpiduralLabor analgesiaProgrammed intermittent epidural bolus

Outcome Measures

Primary Outcomes (1)

  • Adequate response of the patient, defined as no request for supplemental analgesia

    Adequate response of the patient, defined as 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

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 60-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: BupivacaineDrug: FentanylDevice: Infusion pump

50 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 50-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: BupivacaineDrug: FentanylDevice: Infusion pump

40 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 40-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: BupivacaineDrug: FentanylDevice: Infusion pump

30 minutes

EXPERIMENTAL

The infusion pump will deliver programmed intermittent epidural boluses at a 30-minute interval. The bolus will consist of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml. A PCEA bolus of 5mL of 0.125% Bupivacaine plus fentanyl 2mcg/ml will also be available.

Drug: BupivacaineDrug: FentanylDevice: Infusion pump

Interventions

BupivacaineDRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

Also known as: Marcaine
30 minutes40 minutes50 minutes60 minutes
FentanylDRUG

0.125% Bupivacaine plus fentanyl 2mcg/ml

30 minutes40 minutes50 minutes60 minutes
Infusion pumpDEVICE

Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).

Also known as: CADD-Solis Ambulatory Infusion Pump
30 minutes40 minutes50 minutes60 minutes

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA 2 or 3
  • Full term (≥ 37 weeks gestation)
  • Nulliparous
  • Singleton pregnancy, vertex presentation
  • Active labor: regular painful contractions occurring at 3-at least every 5 minutes and change in cervix
  • Verbal Numerical Pain Score (VNPS) at requesting analgesia \> 5 (VNPS 0-10)
  • Cervical dilatation ≥2 ≤ 5 cm

You may not qualify if:

  • Refusal to provide written informed consent.
  • Any contraindication to epidural anesthesia
  • Unintentional 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

Location

MeSH Terms

Conditions

Labor Pain

Interventions

BupivacaineFentanylInfusion Pumps

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 2, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)