Phase 3
N=93
Lidocaine Patches After Cesarean Section
Postoperative Pain · Obstetric Pain · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04443569 ↗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
| Outcome | Result | p-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
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.