Evaluate the Depth and Duration of Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers

NCT01688518

Healthy

COMPLETED PHASE1

Pharmacokinetic Study of Synera in Healthy Volunteers

NCT01602757

Healthy

COMPLETED PHASE1

In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?

NCT01576770

Pain on Propofol IV Injection

UNKNOWN PHASE4

Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy

NCT01111773

Patellar Tendinopathy

COMPLETED PHASE2

Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points

NCT01106989

Myofascial Pain Syndromes

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Synera

Group Type EXPERIMENTAL

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)

Intervention Type DRUG

30 minute applicable on antecubital fossa

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)

30 minute applicable on antecubital fossa

Intervention Type DRUG

Placebo Patch

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Had no known significant diseases
* Normal 12-lead electrocardiogram
* Willing to refrain from using any local topical preparations

Exclusion Criteria

* Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
* Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
* Had an active dermatological disease of any origin that may have interfered with their ability to participate

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes