NCT05767749

Split Face Study of the Duration of Local Anesthetics

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will compare the relative durations of local anesthetics within the same subject at a highly vascularized anatomic region of skin, the nasal ala. This study will test and compare the relative durations and efficacy of commonly used long acting (ropivacaine or bupivacaine) and short acting local anesthetics (lidocaine with epinephrine), delivered via local anesthesia. This study will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthetic.

Conditions

• Anesthetics, Local

Interventions

Type	Name	Description
DRUG	lidocaine + epinephrine 1:100,000	0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.
DRUG	Ropivacaine 0.5% Injectable Solution	0.5 ml Ropivacaine 0.5% Injectable Solution
DRUG	Bupivacaine 0.5% Injectable Solution	0.5ml bupivacaine 0.5%

Timeline

• Start date: 2023-03-14
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2023-03-14
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study