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

NCT06242977 | Recruiting Phase 3

• 1 other identifier: HS25862 (H2023:047)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scrotum Disease; Hydrocele Male; Spermatocele; Scrotal Hematocele; Local Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention arm - EMLA cream

EXPERIMENTAL

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)

Control arm - Control cream

PLACEBO COMPARATOR

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

Interventions

Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA) DRUG

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

Also known as: EMLA

Intervention arm - EMLA cream

Control cream OTHER

This intervention will be for the control group, a simple lotion cream.

Also known as: Moisturizing cream

Control arm - Control cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

RECRUITING

Related Publications (1)

• Chung D, Bal DS, Morra M, Shah J, Fidel MG, Dhillon H, Van Heerden H, Nayak JG, Patel P. Efficacy of EMLA for Office-based Andrology Procedures Under Local Anesthesia: A Randomized Control Trial. Urology. 2024 Oct;192:6-11. doi: 10.1016/j.urology.2024.07.004. Epub 2024 Jul 5.

  PMID: 38972394 DERIVED

MeSH Terms

Conditions

Spermatocele; Hematocele

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Cysts; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The surgeon and patient are both blinded to which cream is being utilized, whether it be EMLA, or a control cream. Investigators and study personelle are not blinded to this.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Model Details: Double blinded, placebo controlled, randomized trial. Two arms, one is the intervention arm which will receive EMLA cream and local anesthesia infiltration while the control arm will receive local anesthesia infiltration and a control, lotion cream.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 5, 2024
• Study Start: January 25, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 30, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

CA (1)