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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CADD-Solis Ambulatory Infusion System
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

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA II or III
  • Term pregnancy (gestational age ≥ 37 weeks)
  • Nulliparous
  • Singleton pregnancy with vertex presentation
  • Active labour defined as occurring regular uterine contractions at least every 5 minutes with progressive cervical dilatation
  • Verbal Numerical Rating Score (VNRS) greater than 5 at requiring epidural analgesia (VNRS 0-10)
  • Cervical dilation between 2 and 5 cm

Exclusion Criteria:

  • Any contraindication to epidural analgesia
  • Accidental dural puncture
  • Drug allergy to lidocaine, bupivacaine or fentanyl
  • Use of pharmacological analgesics within the last 4 hours
  • Patient refusal to participate in the trial

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PIEB speed of infusion 250 ml/hr

PIEB speed of infusion 125 ml/hr

Arm Description

The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 250 ml/hr by the CADD-Solis Ambulatory Infusion System.

The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 125 ml/hr by the CADD-Solis Ambulatory Infusion System.

Outcomes

Primary Outcome Measures

Sensory block level to ice equal to or higher than T6 within the study period (6 hours)
Sensory block to ice will be assessed bilaterally at the mid-clavicular line, and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek). T6 is defined as the level of the xyphoid process.

Secondary Outcome Measures

Sensory block level to ice
Sensory block to ice will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek).
Sensory block level to pin prick
Sensory block to pin prick will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient initial begins to feel normal sharp sensation compared to a control site (lateral upper arm, frontal part of head or cheek).
Motor block level assessed using Bromage score
Motor block will be assessed hourly 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.
Pain score
Pain score measured hourly (for up to 6 hours) using VNRS (0-10)
Total number of PCEA demands
The number of times a patient presses the button to request additional analgesia.
Total number of rescue boluses administered
The number of actual boluses administered by the patient, nurse or physician (for up to 6 hours).
Total amount of local anesthetic (ml)
The total amount of local anesthetic consumption over the study period (by programmed intermittent bolus and any rescue boluses, for up to 6 hours).
Maternal satisfaction rating
Maternal satisfaction rating using VNRS (0-10), 0=not at all satisfied, 10=most satisfied Rating at the end of the 6 hour study period.
Hypotension
A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural), during the 6 hour study period.

Full Information

First Posted
July 12, 2017
Last Updated
March 19, 2020
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03236298
Brief Title
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow
Official Title
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: a RCT Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (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 comparing to a conventional continuous infusion. The use of this PIEB technique in routine practice has reduced the total consumption of local anesthetic and the percentage of patients requesting additional boluses (PCEA or manual rescues). However, at the same time, sensory blocks above those targeted for labor pain relief have been reported in our institution, suggesting that the spread of the freezing medication is wider than necessary. Based on the information already available in the literature, the investigators will conduct this study to determine the best regimen of PIEB achievable with a slower delivery speed. The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the incidence of women presenting sensory block to ice equal or higher than T6 as compared to a delivery rate of 250 mL/h.
Detailed Description
PIEB is a novel technique, which provides better analgesia and less motor block; however, the ideal regimen has not been established. To optimize the PIEB regimen, the investigators have conducted several clinical trials using bupivacaine with fentanyl. Although PIEB provides the excellent analgesia to laboring parturients, studies completed by the instigators have shown that the incidence of sensory block to ice ≥T6 was 66%. For labor analgesia during the first stage of labor, effective sensory block requires T10 to L1; therefore, a sensory block ≥T6 seems unnecessarily high, and the investigators seek to confine epidural spread within a proper range. Our previous studies showed that the effective volume 90% using 0.0625% bupivacaine was 10.7 mL, and incidence of epidural blockade ≥T6 was similar even using a 5-mL bolus with 0.125% bupivacaine. The investigators concluded that it is not possible to reduce volume of the PIEB, or use a higher concentration of local anesthetic without compromising the quality of analgesia. There is some evidence in the literature that supports the idea that higher injection pressures result in a wider spread of local anesthetic administered into the epidural space, therefore a slower epidural delivery flow rate may result in less spread.

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
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIEB speed of infusion 250 ml/hr
Arm Type
Active Comparator
Arm Description
The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 250 ml/hr by the CADD-Solis Ambulatory Infusion System.
Arm Title
PIEB speed of infusion 125 ml/hr
Arm Type
Active Comparator
Arm Description
The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 125 ml/hr by the CADD-Solis Ambulatory Infusion System.
Intervention Type
Device
Intervention Name(s)
CADD-Solis Ambulatory Infusion System
Intervention Description
The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
Primary Outcome Measure Information:
Title
Sensory block level to ice equal to or higher than T6 within the study period (6 hours)
Description
Sensory block to ice will be assessed bilaterally at the mid-clavicular line, and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek). T6 is defined as the level of the xyphoid process.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Sensory block level to ice
Description
Sensory block to ice will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek).
Time Frame
6 hours
Title
Sensory block level to pin prick
Description
Sensory block to pin prick will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient initial begins to feel normal sharp sensation compared to a control site (lateral upper arm, frontal part of head or cheek).
Time Frame
6 hours
Title
Motor block level assessed using Bromage score
Description
Motor block will be assessed hourly 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
Pain score
Description
Pain score measured hourly (for up to 6 hours) using VNRS (0-10)
Time Frame
6 hours
Title
Total number of PCEA demands
Description
The number of times a patient presses the button to request additional analgesia.
Time Frame
6 hours
Title
Total number of rescue boluses administered
Description
The number of actual boluses administered by the patient, nurse or physician (for up to 6 hours).
Time Frame
6 hours
Title
Total amount of local anesthetic (ml)
Description
The total amount of local anesthetic consumption over the study period (by programmed intermittent bolus and any rescue boluses, for up to 6 hours).
Time Frame
6 hours
Title
Maternal satisfaction rating
Description
Maternal satisfaction rating using VNRS (0-10), 0=not at all satisfied, 10=most satisfied Rating at the end of the 6 hour study period.
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), during the 6 hour study period.
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA II or III Term pregnancy (gestational age ≥ 37 weeks) Nulliparous Singleton pregnancy with vertex presentation Active labour defined as occurring regular uterine contractions at least every 5 minutes with progressive cervical dilatation Verbal Numerical Rating Score (VNRS) greater than 5 at requiring epidural analgesia (VNRS 0-10) Cervical dilation between 2 and 5 cm Exclusion Criteria: Any contraindication to epidural analgesia Accidental dural puncture Drug allergy to lidocaine, bupivacaine or fentanyl Use of pharmacological analgesics within the last 4 hours Patient refusal to participate in the trial
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
Citations:
PubMed Identifier
34725792
Citation
Mazda Y, Arzola C, Downey K, Ye XY, Carvalho JCA. Programmed intermittent epidural bolus for labour analgesia: a randomized controlled trial comparing bolus delivery speeds of 125 mL.hr-1 versus 250 mL.hr-1. Can J Anaesth. 2022 Jan;69(1):86-96. doi: 10.1007/s12630-021-02132-w. Epub 2021 Nov 1.
Results Reference
derived

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Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow

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