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NCT04443569 · ClinicalTrials.gov registry record · Phase 3
Lidocaine Patches After Cesarean Section
A Phase 3 study of Postoperative Pain and Opioid Use, sponsored by Yale University.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
- 1
- Study location
NCT04443569: Completed Phase 3 study of Postoperative Pain and Opioid Use, sponsored by Yale University.
NCT04443569 is a Phase 3 study of Postoperative Pain and Opioid Use that has completed, run by Yale University. The registered enrollment target is 93 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04443569, a Phase 3 study of Postoperative Pain and Opioid Use, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain.
Conditions Studied
Interventions
- DRUG Lidocaine patch
- OTHER Placebo patch
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2021-10-10 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 3 |
What the finished NCT04443569 record still lists
NCT04443569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine patch is the first listed.
NCT04443569 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04443569 about?
NCT04443569 is a clinical study titled "Lidocaine Patches After Cesarean Section". 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 anal...
What is the current status of trial NCT04443569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2021-10-10. Estimated completion is 2022-08-31.
What conditions does trial NCT04443569 study?
This clinical trial studies the following conditions: Postoperative Pain, Opioid Use, Obstetric Pain.
What interventions are being tested in trial NCT04443569?
The interventions under investigation include: Lidocaine patch (DRUG), Placebo patch (OTHER).
Who is sponsoring clinical trial NCT04443569?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04443569 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04443569's enrollment target sits among peer trials
93 65th of 120 higher than 56 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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