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Lidocaine Patches After Cesarean Section

NCT04443569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-11-06

Study results available
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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.

Conditions

  • Postoperative Pain
  • Obstetric Pain
  • Opioid Use

Interventions

DRUG

Lidocaine patch

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

OTHER

Placebo patch

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

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Audrey Merriam, MD, MS · Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

  • Christopher Arkfeld, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443569 on ClinicalTrials.gov