Phase 4
N=150
Split Face Study of the Duration of Local Anesthetics
Anesthetics, Local
Bottom Line
View on ClinicalTrials.gov: NCT05767749 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments — 54.34; 49.86; 43.13; 55.78 Minutes — p=0.93
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lidocaine + epinephrine 1:100,000 (Drug); Ropivacaine 0.5% Injectable Solution (Drug); Bupivacaine 0.5% Injectable Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments |
54.34; 49.86; 43.13; 55.78; 52.33; 46.16 | 0.93 |
Summary
This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. This study will compare a short-acting anesthetic, lidocaine with epinephrine, to one of two long-acting anesthetics (ropivacaine or bupivacaine). This study will also directly compare the duration of actions of ropivacaine and bupivacaine. The investigators hypothesize that the duration of anesthesia of short-acting anesthetics will not differ significantly from long-acting anesthetics at a single site and there will not be a significant difference between the two long-acting anesthetics at a single site.
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age
- Normal skin sensation at both nasal ala assessed by pinprick
- Ability to provide informed consent
Exclusion Criteria
- Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
- Pregnant or breastfeeding volunteers (assessed by self-report)
- Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
Data sourced from ClinicalTrials.gov (NCT05767749). 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.