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Local Anesthetic

Intervention arm - EMLA cream for Swollen scrotum

Phase 3

Recruiting

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post-operation

Awards & highlights

Study Summary

This trial aims to compare the use of local anesthesia alone versus the use of local anesthesia with a topical anesthetic cream for scrotal urologic surgeries. The goal is to see if adding the

Who is the study for?

This trial is for individuals undergoing outpatient scrotal surgery, such as for hydrocele or spermatocele. Participants must be suitable for local anesthesia without the need for hospital-based sedation or general anesthesia.Check my eligibility

What is being tested?

The study tests if applying EMLA cream (a topical anesthetic) to the scrotum before surgery can increase patient comfort compared to a control cream. It aims to see if this method can improve tolerability of office-based andrology procedures.See study design

What are the potential side effects?

EMLA cream may cause side effects like mild skin irritation, redness, or itching at the site of application. More serious reactions are rare but could include allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately post-infiltration, intraoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately post-infiltration, intraoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-infiltration, intraoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain with local anesthetic infiltration

Procedural pain

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention arm - EMLA creamExperimental Treatment1 Intervention

This arm will receive EMLA cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite.

Group II: Control arm - Control creamPlacebo Group1 Intervention

This arm will receive lotion cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,409 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"As per the details available on clinicaltrials.gov, this investigation is actively enrolling volunteers. The trial was first listed on January 25th, 2024, and the latest update was made on February 2nd of the same year."

Answered by AI

Are individuals aged 85 years and older being actively recruited for participation in this study?

"Potential participants must be of legal age, with the lower limit being 18 years and upper threshold at 65 years to partake in this research endeavor."

Answered by AI

Has the intervention group been verified by the FDA for EMLA cream use?

"According to our evaluation at Power, the safety rating for the Intervention arm - EMLA cream is 3. This reflects the advanced stage of this trial and signifies a foundation of efficacy data along with robust safety information."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedures

Premal Patel, MD 2024. "Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242977.