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Phase 3 N=93 Randomized Single-blind Treatment

Lidocaine Patches After Cesarean Section

Postoperative Pain · Obstetric Pain · Opioid Use

Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Visual Analog Pain Score — 3.5; 4.1; 5.2; 5.2 score on a scale — p=0.3

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Lidocaine patch (Drug); Placebo patch (Other)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Yale University
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Pain Score
3.5; 4.1; 5.2; 5.2; 5.2; 4.3 0.3
SECONDARY
Narcotic Use
51.3; 29.7 0.02 sig

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.

Eligibility Criteria

Inclusion Criteria

  • Female
  • Primary or secondary cesarean delivery
  • Able to consent to research study

Exclusion Criteria

  • 3 or more prior cesarean deliveries
  • History of abdominoplasty
  • History of abdominal hernia repair with mesh
  • Allergy to lidocaine
  • Allergy to adhesives in medical tape
  • Women who received general anesthesia for their cesarean delivery
  • Women with active substance abuse
  • Women methadone or suboxone for a history of opiate abuse
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04443569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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