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

February 2, 2024 updated by: Premal Patel, MD, University of Manitoba

Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedure: A Randomized Controlled Study

Scrotal, urologic surgery has traditionally been conducted in the hospital setting, typically with the use of sedation, spinal anesthesia or general anesthesia. There has been a recent push to move certain scrotal urologic surgeries out of the hospital operating room into a ambulatory, outpatient basis with recent literature demonstrating this in many centers. The use of local anesthesia alone poses numerous benefits. The investigators wish to compare patients who are undergoing invasive scrotal surgery under local anesthetic to those who additionally have a topical anesthetic cream (EMLA) applied to the scrotum to determine if this further increases patient tolerability of these procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current standard of care for patients undergoing the majority of urologic procedures is to administer general or spinal anesthesia. The use of general or spinal anesthesia can lead to several complications, long wait times, higher costs associated with the operating. While office-based surgical procedures under local anesthesia can have additional benefits aside from avoiding adverse effects of spinal or general anesthesia, such as ability to communicate, improved convenience, and absence of extended post-op recovery. In one particular study, patients who were surveyed were overwhelmingly satisfied with office-based procedures, and often perceived office-based procedures as less invasive and safer. Urologic care has much to gain from expanding the use of procedures performed under local anesthetic in an ambulatory setting to address the above problems.

Although local anesthetic can be quite effective, needle phobia and negative experiences associated with it can be a common experience. In addition to the fear associated with injection, the traditional local anesthetic injection can also be associated with pain and trauma to the infiltrated site. EMLA (Eutectic Mixture of Local Anesthetic) is a topic anesthetic cream that has in various office based urology procedures. Its use and potential benefits has been seen in a few studies for use in no-scalpel vasectomy, circumcision, metatomy, and more. However its use in more involved/invasive andrology and male-infertility procedures such as hydrocelectomy, penile plications, and others remain poorly studied thus far. Anecdotally, use of EMLA cream as an adjunct to our local anesthetic protocol demonstrated good efficacy in pain control and patient tolerability.

As such, the investigators wish to perform a prospective randomized controlled study at the Manitoba Men's Health Clinic to assess whether or not the use of EMLA cream and local anesthetic nerve block is associated with improved pain tolerance than local anesthetic alone. If our hypothesis provides true, further implementation of EMLA cream in office based andrology and male-infertility procedures may provide better pain control and overall experience for patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3K 1M3
        • Recruiting
        • Men's Health Clinic Manitoba
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients undergoing hydrocelectomy, spermatocelectomy, epididymectomy, testicular biopsy, scrotal lesion or cyst excision under local anesthesia alone were included.

Exclusion Criteria:

  • Patients were excluded if their procedure was to be performed with sedatives (e.g., inhaled nitrous oxide gas, oral, or IV sedation) or did not provide consent to be randomized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm - EMLA cream
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.
Drug: Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA)
The intervention is the utilization of EMLA cream, a topical anesthetic to determine if this reduces pain with local anesthesia infiltration, and for overall procedural pain
Other Names:
  • EMLA
Placebo Comparator: Control arm - Control cream
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.
Other: Control cream
This intervention will be for the control group, a simple lotion cream.
Other Names:
  • Moisturizing cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain with local anesthetic infiltration
Time Frame: Immediately post-infiltration, intraoperatively
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient when the local anesthetic injection is administered
Immediately post-infiltration, intraoperatively
Procedural pain
Time Frame: Immediately post-operation
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient post-operatively to determine their pain
Immediately post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS25862 (H2023:047)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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