Split Face Study of the Duration of Local Anesthetics

Phase 4

Completed

• Conditions: Anesthetics, Local
• Interventions: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Bupivacaine 0.5% Injectable Solution

• Registration Number: NCT05767749
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Study Start: 2023-03-14
• Study First Posted: 2023-03-14
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine + epinephrine vs Ropivacaine	Ropivacaine 0.5% Injectable Solution	Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of . Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) and 0.5ml of Naropin (ropivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.
Lidocaine + epinephrine vs Bupivacaine	Bupivacaine 0.5% Injectable Solution	Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of lidocaine + epinephrine into one side of the nose (nasal ala) and 0.5ml of Marcaine (bupivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.
Ropivacaine vs Bupivacaine	Ropivacaine 0.5% Injectable Solution	Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) and 0.5ml of Marcaine (bupivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.
Ropivacaine vs Bupivacaine	Bupivacaine 0.5% Injectable Solution	Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) and 0.5ml of Marcaine (bupivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States