Phase 4
N=50
Post-Op Lidocaine Patch
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03500211 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: 12-hour Postoperative Pain Scores — 33.5; 28.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidoderm 5 % Topical Patch (Drug); Sham Topical Patch (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-hour Postoperative Pain Scores |
33.5; 28.8 | — |
| PRIMARY 24-hour Postoperative Pain Scores |
34.1; 32.9 | — |
| PRIMARY 36-hour Postoperative Pain Scores |
37.3; 43.0 | — |
| PRIMARY 48-hour Postoperative Pain Scores |
24.8; 29.6 | — |
| SECONDARY 5-days Postoperative Narcotic Use |
8.6; 8.3 | — |
Summary
Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.
Eligibility Criteria
Inclusion Criteria
- Pregnant patients who require a scheduled or non-urgent cesarean birth
- Patient able to receive neuraxial analgesia
- Patient able to give verbal and written consent for both cesarean birth and study
Exclusion Criteria
- Patients requiring emergent cesarean birth
- Patients allergic to lidocaine or adhesive
- Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
- Patients using chronic oral neuromodulators
- Patients with cardiac disease or using anti-arrhythmic agents
- Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
- Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.
Data sourced from ClinicalTrials.gov (NCT03500211). 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.