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Programmed Intermittent Epidural Bolus Time Interval and Injection Volume

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00417027
First received: December 27, 2006
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

Studies suggest that administration of maintenance epidural solutions as programmed or automated intermittent boluses, rather than continuous infusions, result in lower bupivacaine consumption, decreased need for manual boluses by the anesthesiologist, and greater patient satisfaction. In this technique, the epidural maintenance dose is administered as a bolus by the infusion pump at regular intervals instead of as a continuous infusion. However, the optimal combination of bolus volume and dosing interval has not been determined. At one end of the spectrum, a small volume and short bolus dose interval will likely behave like a continuous infusion. At the other end of the spectrum, a large volume and long bolus dose interval may lead to an increased incidence of breakthrough pain. The purpose of this randomized, double-blind trial was to determine how manipulation of the programmed intermittent time interval and volume influences total drug use, quality of analgesia, and patient satisfaction during maintenance of labor analgesia. We hypothesized that manipulation of the programmed intermittent bolus time interval and volume during the maintenance of epidural labor analgesia influences total drug use, quality of analgesia and patient satisfaction.


Condition Intervention
Labor Pain
Procedure: Programmed Intermittent Epidural Bolus (PIEB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Manipulation of the Programmed Intermittent Bolus Time Interval and Injection Volume on Total Drug Use for Labor Epidural Analgesia: a Randomized Controlled Trial

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia. [ Time Frame: From initiation of labor analgesia until delivery less than 24 hours ] [ Designated as safety issue: No ]
    Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.


Secondary Outcome Measures:
  • Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
    The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.

  • Patient Controlled Bolus Attempts [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
    The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.

  • Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
    Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.

  • Manual Bolus Doses Administered [ Time Frame: Duration of labor analgesia ] [ Designated as safety issue: No ]
  • Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number. [ Time Frame: 3 hours after initiation of labor analgesia ] [ Designated as safety issue: No ]
    Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.

  • Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery. [ Time Frame: 24 hours following labor analgesia ] [ Designated as safety issue: No ]
    Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.


Enrollment: 190
Study Start Date: August 2006
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2.5 mL bolused every 15 minutes Procedure: Programmed Intermittent Epidural Bolus (PIEB)
A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes.
Other Name: Hospira Gemstar infusion pump
Active Comparator: 5ml bolused every 30 minutes Procedure: Programmed Intermittent Epidural Bolus (PIEB)
A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes.
Other Name: Hospira Gemstar infusion pump
Active Comparator: 10ml bolused every 60 minutes Procedure: Programmed Intermittent Epidural Bolus (PIEB)
A commercial pump that can be programmed to administer intermittent boluses and patient controlled boluses does not exist. Two pumps were prepared for each subject with the same epidural solution. One pump was programmed to administer the programmed intermittent epidural bolus(PIEB). The second pump was programmed to administer patient controlled epidural analgesia (PCEA)with a dose of 5 mL delivered with a lockout of every 10 minutes.
Other Name: Hospira Gemstar infusion pump

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • nulliparous women
  • term gestation (greater than or equal to 37 weeks gestation)
  • spontaneous labor or with spontaneous rupture of membranes

Exclusion Criteria:

  • Systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
  • use of chronic analgesic medications
  • systemic opioid labor analgesia prior to the initiation of neuraxial labor analgesia
  • cervical dilation less than 2cm or greater than 5cm at time of initiation of neuraxial analgesia
  • delivery within 90 minutes of intrathecal injection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417027

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
  More Information

Publications:

Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00417027     History of Changes
Other Study ID Numbers: 0524-027
Study First Received: December 27, 2006
Results First Received: June 28, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Patient controlled epidural analgesia
Labor analgesia
Epidural analgesia

Additional relevant MeSH terms:
Labor Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014