Clinical trial

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

Name

22-10025244

Description

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.

Trial arms

Trial start

2023-03-14

Estimated PCD

2023-07-31

Trial end

2023-07-31

Status

Completed

Phase

Early phase I

Treatment

lidocaine + epinephrine 1:100,000

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

Arms:

Lidocaine + epinephrine vs Bupivacaine, Lidocaine + epinephrine vs Ropivacaine

Other names:

Xylocaine + epinephrine 1:100,000

Ropivacaine 0.5% Injectable Solution

0.5 ml Ropivacaine 0.5% Injectable Solution

Arms:

Lidocaine + epinephrine vs Ropivacaine, Ropivacaine vs Bupivacaine

Other names:

Naropin

Bupivacaine 0.5% Injectable Solution

0.5ml bupivacaine 0.5%

Arms:

Lidocaine + epinephrine vs Bupivacaine, Ropivacaine vs Bupivacaine

Other names:

Marcaine

Size

Primary endpoint

Time to Return to Baseline Sensation, as determined by binary outcomes (yes/no) in 15 minute increments

Up to 4 hours.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '0.5mL of local anesthetic will be injected into the skin of each participant by the one dermatologic surgeon (PI of the study, Dr. Kira Minkis, KM). Dr. Minkis will be unblinded to the laterality of the anesthetics and will not be involved in further assessments.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

Updated at

2023-11-15

1 organization

3 products

2 indications

Organization

Weill Medical College of Cornell University

Product

Lidocaine + Epinephrine

Indication

Indication

Product

Product