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N/A N=190 Randomized Double-blind Treatment

Programmed Intermittent Epidural Bolus Time Interval and Injection Volume

Labor Pain

Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia. — 11.3; 11.1; 10.3 mg bupivacaine per hour — p=>0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Programmed Intermittent Epidural Bolus (PIEB) (Procedure)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Northwestern University
Primary completion
Mar 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.
11.3; 11.1; 10.3 >0.05
SECONDARY
Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve
15; 13; 14 0.54
SECONDARY
Patient Controlled Bolus Attempts
10; 10; 8 0.32
SECONDARY
Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered
7; 6; 6 0.69
SECONDARY
Manual Bolus Doses Administered
24; 30; 27; 23; 17; 17 0.72
SECONDARY
Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.
6; 5; 5; 11; 12; 9 0.41
SECONDARY
Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.
90; 94; 93 0.85

Summary

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00417027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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