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

NCT03236298 | Completed

• 1 other identifier: 17-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Epidural; Labor analgesia; Programmed intermittent epidural bolus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sensory block level to ice

  6 hours

• Sensory block level to pin prick

  6 hours

• Motor block level assessed using Bromage score

  6 hours

• Pain score

  6 hours

• Total number of PCEA demands

  6 hours

Study Arms (2)

PIEB speed of infusion 250 ml/hr

ACTIVE COMPARATOR

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

PIEB speed of infusion 125 ml/hr

ACTIVE COMPARATOR

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

Interventions

CADD-Solis Ambulatory Infusion System DEVICE

The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.

PIEB speed of infusion 125 ml/hr; PIEB speed of infusion 250 ml/hr

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 34725792 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: July 12, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2017
• Primary Completion: January 22, 2020
• Study Completion: January 23, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)