drugset / Trial / NCT03307174

Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.

NCT03307174 ↗

Phase 4 Completed 120 enrolled University of California, San Francisco
RandomizedParallel-groupSingle-blindTreatment

Summary

Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

Timeline

Start
2016-04-14
Primary completion
2019-02-28
Completion
2019-02-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Continuous Epidural Infusion vs Programmed Intermittent Epidural Bolus; p = 0.74; Wilcoxon (Mann-Whitney) NCT03307174 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.0625 % Other
Subject Fentanyl Other / unclassified 2 ug/ml Other

Indications

No indication recorded.