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A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion
Sponsor: Giorgio Veneziano
Summary
The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. The comparative efficacy of the two interventions will be primarily determined by assessing pain scores at frequent intervals in the first three postoperative days. Secondary outcomes examined over this period will include opioid consumption, number of epidural pump interventions, incidence of epidural insertion site leakage and/or early catheter discontinuation, time to full diet, and incidence of postoperative hypotension.
Official title: A Pilot Study Comparison of Postoperative Analgesia Using Two Modes of Local Anesthetic Epidural Delivery After Bladder Exstrophy Repair: Programmed Intermittent Bolus Versus Continuous Infusion
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-11
Completion Date
2028-12
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
Ropivacaine (Epidural analgesia) intermittent bolus
Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 mL/kg every 60 minutes
Ropivacaine (Epidural analgesia) continuous infusion
Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 ml/kg/hr
Chloroprocaine intermittent bolus
Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.25 ml/kg every 30 minutes
Chloroprocaine continuous infusion
Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.5 ml/kg/hr
Locations (1)
Nationwide Children's Hospital
Columbus, Ohio, United States