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临床试验/NCT06242977
NCT06242977招募中3 期

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

University of Manitoba1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
72
试验地点
1
主要终点
Pain with local anesthetic infiltration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

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.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA) (Drug)

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.

干预措施: Control cream (Other)

结局指标

主要结局

Pain with local anesthetic infiltration

时间窗: 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

Procedural pain

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Premal Patel, MD

Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

University of Manitoba

研究点 (1)

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