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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine
Fentanyl
Infusion pump
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Epidural, Labor analgesia, Programmed intermittent epidural bolus

Eligibility Criteria

16 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

60 minutes

50 minutes

40 minutes

30 minutes

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sensory block level
Sensory block to ice will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient still does not feel cold sensation as compared to a control site (frontal part of the head)
Motor block level assessed using Bromage score
Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.
Hypotension
A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural).
Pain score
Pain score measured hourly using VNRS (0-10)

Full Information

First Posted
April 29, 2016
Last Updated
May 23, 2017
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02758405
Brief Title
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2
Official Title
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 5 of Bupivacaine 0.125% Plus Fentanyl 2 mcg/ml.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Studies involving programmed intermittent epidural bolus (PIEB) to date have provided an analgesic regimen that delivered an amount of local anesthetic that was below the patient's requirement per hour, as the studies were done in the context of an association with patient controlled epidural anesthesia (PCEA) as a rescue technique. As a result, PCEA requests were frequent and therefore these studies have not been able to truly understand the pharmacology of the bolus technique in the PIEB regimen, as the PCEA utilized by patients added an extra component to the regimen. At Mount Sinai Hospital, PIEB devices have been recently introduced. Currently our standard epidural mixture is bupivacaine 0.0625% with fentanyl 2mcg/ml. Based on previous research done by the investigators, the current epidural regimen consists of 10 ml PIEB at 40 minute intervals, with PCEA boluses of 5 ml and a lock out interval of 10 minutes, for a maximum of 20 ml of the epidural mixture per hour. In this study, the investigators will offer patients 5mL PIEBs of bupivacaine 0.125% with fentanyl 2mcg/ml at 4 different intervals. PCEA bolus of 5mL of the same solution will also be available. The goal is to establish the ideal PIEB regimen that will be effective for our patient population using a higher concentration epidural mixture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Epidural, Labor analgesia, Programmed intermittent epidural bolus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 minutes
Arm Type
Experimental
Arm Description
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.
Arm Title
50 minutes
Arm Type
Experimental
Arm Description
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.
Arm Title
40 minutes
Arm Type
Experimental
Arm Description
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.
Arm Title
30 minutes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
0.125% Bupivacaine plus fentanyl 2mcg/ml
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
0.125% Bupivacaine plus fentanyl 2mcg/ml
Intervention Type
Device
Intervention Name(s)
Infusion pump
Other Intervention Name(s)
CADD-Solis Ambulatory Infusion Pump
Intervention Description
Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
Primary Outcome Measure Information:
Title
Adequate response of the patient, defined as no request for supplemental analgesia
Description
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).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Sensory block level
Description
Sensory block to ice will be assessed bilaterally at the mid axillary lines, and the level of block will be the level at which the patient still does not feel cold sensation as compared to a control site (frontal part of the head)
Time Frame
6 hours
Title
Motor block level assessed using Bromage score
Description
Motor block will be assessed with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.
Time Frame
6 hours
Title
Hypotension
Description
A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural).
Time Frame
6 hours
Title
Pain score
Description
Pain score measured hourly using VNRS (0-10)
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2

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