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

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ClinicalTrials.gov Identifier: NCT03044392
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Allana, IWK Health Centre

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.


Condition or disease Intervention/treatment Phase
Labor Pain Other: Next Bolus Interval Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Optimal "Next Bolus" Interval for Programmed Intermittent Bolus Epidural Analgesia: A Randomized Controlled Trial
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : June 5, 2019
Estimated Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Next Bolus Interval 15 minutes
Next Bolus Interval 15 minutes
Other: Next Bolus Interval
Next Bolus Interval 15, 30, or 45 minutes
Other Name: Time from start of epidural pump to first dose of medication

Active Comparator: Next Bolus Interval 30 minutes
Next Bolus Interval 30 minutes
Other: Next Bolus Interval
Next Bolus Interval 15, 30, or 45 minutes
Other Name: Time from start of epidural pump to first dose of medication

Active Comparator: Next Bolus Interval 45 minutes
Next Bolus Interval 45 minutes
Other: Next Bolus Interval
Next Bolus Interval 15, 30, or 45 minutes
Other Name: Time from start of epidural pump to first dose of medication




Primary Outcome Measures :
  1. Time to first administered Patient Controlled Epidural Analgesia (PCEA) request [ Time Frame: 360 minutes ]
    The time from the start of the epidural pump to the first administered request for a PCEA bolus (in minutes).


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 360 minutes ]
    Pain Scores (NRS 0-10) - measured at baseline, 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes.

  2. Number of PCEA bolus attempts [ Time Frame: 360 minutes ]
    The number of times the patient presses a button requesting a PCEA bolus in the first 360 minutes or until delivery.

  3. Number of PCEA bolus received [ Time Frame: 360 minutes ]
    The number of PCEA boluses actually administered by the pump in the first 360 minutes or until delivery.

  4. Number of manual bolus doses administered by the anesthesiologist [ Time Frame: 360 minutes ]
    The number of times an anesthesiologist had to administer a manual bolus because pain was inadequately controlled with PCEA in the first 360 minutes or until delivery.

  5. Total local anesthetic consumption after pump initiation [ Time Frame: 360 minutes ]
    mg of ropivicaine 0.1% calculated by the CADD pump in the first 360 minutes or until delivery.

  6. Highest thoracic dermatome sensory level [ Time Frame: 360 minutes ]
    Measured by pin-prick at 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes.

  7. Modified Bromage scores measured at 60, 120, 180, 240, 300, and 360 minutes [ Time Frame: 360 minutes ]
    Measures motor blockade, recorded at 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes

  8. Maternal satisfaction with labour analgesia [ Time Frame: 360 minutes ]
    0-100%, measured within 24 hours of delivery.

  9. Occurrence of hypotension [ Time Frame: 360 minutes ]
    Defined as a 20% drop of blood pressure from baseline. Measured at baseline, 0, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044392


Contacts
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Contact: Allana Munro, MD FRCPC 902-470-6627 ammunro@dal.ca
Contact: Ronald George, MD FRCPC 902-470-6627 rbgeorge@dal.ca

Locations
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Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Research Services    902-470-7879      
Sponsors and Collaborators
IWK Health Centre
Investigators
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Principal Investigator: Allana Munro IWK Health Centre

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Responsible Party: Allana, Anesthesiologist, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03044392    
Other Study ID Numbers: 1021552
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allana, IWK Health Centre:
Programmed Intermittent Epidural Bolus
Labour Analgesia
Pain
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms