N/A
N=190
Programmed Intermittent Epidural Bolus Time Interval and Injection Volume
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT00417027 ↗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
| Outcome | Result | p-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
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.