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

HS25862 (H2023:047)

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.

2024-01-25

2024-08-15

2024-08-30

Recruiting

Early phase I

72

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

2024-02-05