drugset / Trial / NCT07839039

A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion

NCT07839039 ↗

Not yet recruiting 10 enrolled Giorgio Veneziano
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-11
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Chloroprocaine Other / unclassified 1.5 % Other
Subject Ropivacaine Other / unclassified 0.2 % Other

Indications