drugset / Trial / NCT02159807

Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

NCT02159807 ↗

Completed 170 enrolled St. Luke's-Roosevelt Hospital Center
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

Timeline

Start
2015-04-24
Primary completion
2017-12-29
Completion
2017-12-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 1.25 mg Intrathecal
Comparator Bupivacaine Other / unclassified 1.66 mg Intrathecal
Comparator Bupivacaine Other / unclassified 2.5 mg Intrathecal
Comparator Fentanyl Other / unclassified 20 ug Intrathecal

Indications