CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 93 enrolled
Drug / intervention
Lidocaine patch +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04443569
NCT04443569Phase 3Completed
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Lidocaine Patches After Cesarean Section

Yale University·interventional·Posted Jun 23, 2020·Updated Nov 6, 2024

In Brief

A Phase 3 clinical trial evaluating Lidocaine patch and Placebo patch for Postoperative Pain and 2 related conditions. Completed, enrolled 93 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Obstetric Pain, Opioid Use
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 23, 2020
Enrollment StartOct 10, 2021
Primary CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.0 years ago

Interventions

Lidocaine patchdrug

Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management

Placebo patchother

A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.