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

NCT06242977 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-05

No results posted yet for this study

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

Interventions

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

Control cream

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

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2024-08-15
Completion
2024-08-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242977 on ClinicalTrials.gov