drugset / Trial / NCT04443569

Lidocaine Patches After Cesarean Section

NCT04443569 ↗

Phase 3 Completed 93 enrolled Yale University
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to investigate the impact of using lidocaine patches after cesarean section on pain control and opioid use in the immediate post-operative period. The hypothesis is the use of lidocaine patches in the immediate post-operative period will lead to a decrease in the visual analog pain score compared to women who do not use a lidocaine patch in the immediate post-operative period following cesarean delivery. Additionally, a decrease in the use of opioids as pain control compared to patients that do not have a lidocaine patch in place the is anticipated.

Timeline

Start
2021-10-10
Primary completion
2022-08-31
Completion
2022-08-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Lidocaine Patch Group vs Control Group; p = 0.3; t-test, 2 sided NCT04443569 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified — Topical

Indications