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Completed

NCT Number: NCT05767749

Split Face Study of the Duration of Local Anesthetics

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.

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Key information

Conditions

Anesthetics, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine + epinephrine 1:100,000

Drug

0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.

Other names: Xylocaine + epinephrine 1:100,000

Ropivacaine 0.5% Injectable Solution

Drug

0.5 ml Ropivacaine 0.5% Injectable Solution

Other names: Naropin

Bupivacaine 0.5% Injectable Solution

Drug

0.5ml bupivacaine 0.5%

Other names: Marcaine

Primary outcomes

  1. Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments

    Time frame: Up to 4 hours.

    To determine whether the time to return to baseline sensation differs significantly between each pair of anesthetics, the investigators will measure the time to return to baseline sensation at each anesthetized site by asking participants at 15 minute intervals if they can feel a sharp sensation at the site. Sterile needles will be used. The return of the sensitivity will be determined using binary outcomes (yes/no) and recorded on a standardized template. The maximum difference in anesthetic duration that the investigators consider "not different" from a clinical standpoint is 15 minutes.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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