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

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: Recruiting
• Conditions: Local Anesthesia; Spermatocele; Scrotum Disease; Hydrocele Male; Scrotal Hematocele
• Intervention / Treatment: Drug: Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA); Other: Control cream

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: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Premal Patel, MD; Phone Number: 204-221-4476; Email: ppatel5@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3K 1M3
      • Recruiting
      • Men's Health Clinic Manitoba
      • Contact: Premal Patel, MD; Phone Number: 204-221-4476; Email: ppatel5@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain with local anesthetic infiltration	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	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

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2024
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cysts; Hemorrhage; Pathological Conditions, Anatomical; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Spermatocele; Hematocele; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Combined; Anesthetics; Anesthetics, Local; Lidocaine, Prilocaine Drug Combination
• Other Study ID 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