Determination of the Optimal "Next Bolus" Interval for Programmed Intermittent Bolus Epidural Analgesia

NCT03044392 | Terminated

• 1 other identifier: 1021552
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard of practice for the maintenance of epidural analgesia is through use of a continuous infusion pump. Enhanced technology now supports the use of programmed intermittent bolus (PIEB) administration. This novel drug delivery system provides small boluses of local anesthetic and opioid at programmed intervals. Several studies suggest that administration of PIEB allows a more extensive spread of local anesthetic in the epidural space and provides superior labour analgesia compared to traditional continuous epidural infusions. PIEB is associated with lower anesthetic consumption, a shorter second stage of labour and greater patient satisfaction. The authors are focusing on a PIEB setting known as the "Next Bolus". "Next Bolus" (NB) determines when the first PIEB bolus is given after the initiation of the epidural and starting the PIEB pump. Currently we set this to be 15-45 minutes. In an attempt to optimize resources, authors hope to determine the optimal NB interval that will provide adequate analgesia but limit overall drug consumption. An optimally timed next bolus should minimize drug costs and limit nurse and physician intervention by decreasing the need for manual boluses.Increased local anesthetic consumption can cause undesirable side effects such as itchiness, decreased blood pressure and motor blockade. By assigning patients to receive the NB at 15, 30 or 45 minutes the authors hope to find the interval that provides analgesia while minimizing side effects, improving patient safety. If the bolus is given too late then there may be increased pain, less patient satisfaction, and the need for more analgesia in the form of Patient Controlled Epidural Anesthesia or a manual bolus.The authors hope that determining the NB will result in an institutional change to improve patient outcomes and facilitate knowledge transfer. This information will be the first available research to help guide other obstetrical centres using PIEB technology in determining the optimal NB interval.

Conditions

Labor Pain

Keywords

Programmed Intermittent Epidural Bolus; Labour Analgesia; Pain

Outcome Measures

Primary Outcomes (1)

• Time to first administered Patient Controlled Epidural Analgesia (PCEA) request

  The time from the start of the epidural pump to the first administered request for a PCEA bolus (in minutes).

  360 minutes

Secondary Outcomes (9)

• Pain scores

  360 minutes

• Number of PCEA bolus attempts

  360 minutes

• Number of PCEA bolus received

  360 minutes

• Number of manual bolus doses administered by the anesthesiologist

  360 minutes

• Total local anesthetic consumption after pump initiation

  360 minutes

Study Arms (3)

Next Bolus Interval 15 minutes

ACTIVE COMPARATOR

Next Bolus Interval 15 minutes

Other: Next Bolus Interval

Next Bolus Interval 30 minutes

ACTIVE COMPARATOR

Next Bolus Interval 30 minutes

Other: Next Bolus Interval

Next Bolus Interval 45 minutes

ACTIVE COMPARATOR

Next Bolus Interval 45 minutes

Other: Next Bolus Interval

Interventions

Next Bolus Interval OTHER

Next Bolus Interval 15, 30, or 45 minutes

Also known as: Time from start of epidural pump to first dose of medication

Next Bolus Interval 15 minutes; Next Bolus Interval 30 minutes; Next Bolus Interval 45 minutes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
• Spontaneous labour
• Nulliparous parturient
• Single gestations ≥ 36 weeks
• English speaking
• Age 18-45 years
• Vertex presentation
• Requesting an epidural for labour analgesia
• Cervical dilation less than 2 cm or greater than 6 cm at the time of initiation of neuraxial analgesia

You may not qualify if:

• Use of IV opioids within 1 hour of initiating the epidural
• Use of nitrous oxide after initiating the epidural pump
• Contraindications to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
• Abnormal spinal anatomy (i.e. scoliosis, spina bifida, spinal instrumentation)
• Height \< 5'0" or BMI ≥ 40 kg/m2
• Chronic analgesics
• Diseases of pregnancy (i.e. hypertension, preeclampsia, gestational diabetes)
• Severe maternal cardiac disease
• Known fetal anomalies /intrauterine fetal demise
• Physical or psychiatric condition which may impair cooperation

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Labor Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Allana Munro

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 7, 2017
• Study Start: June 5, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)