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

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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: CADD-Solis Ambulatory Infusion System

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PIEB speed of infusion 250 ml/hr; 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.	Device: CADD-Solis Ambulatory Infusion System; The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
Active Comparator: PIEB speed of infusion 125 ml/hr; 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.	Device: CADD-Solis Ambulatory Infusion System; The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 hours
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).	6 hours
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.	6 hours
Pain score	Pain score measured hourly (for up to 6 hours) using VNRS (0-10)	6 hours
Total number of PCEA demands	The number of times a patient presses the button to request additional analgesia.	6 hours
Total number of rescue boluses administered	The number of actual boluses administered by the patient, nurse or physician (for up to 6 hours).	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).	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.	6 hours
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.	6 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Epidural; Labor analgesia; Programmed intermittent epidural bolus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 17-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No