跳至主要内容
临床试验/NCT05970354
NCT05970354已完成4 期

Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial

CAMC Health System2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Visual Analogue Scale Pain Score 3

研究概览

简要总结

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:

• Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?

Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

详细描述

Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies

排除标准

  • Known hypersensitivity to amide anesthetics
  • Pre-existing methemoglobinemia

研究组 & 干预措施

VersaPro Cream

Placebo Comparator

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

干预措施: VersaPro Cream Base for Compounding (Drug)

EMLA Cream

Active Comparator

5 grams will be applied to patient's cervix 7 minutes before gynecological procedure

干预措施: EMLA Cream (Drug)

结局指标

主要结局

Visual Analogue Scale Pain Score 3

时间窗: 2 minutes after speculum removal

Scale of 0-10 on a self-reported pain score

Visual Analogue Scale Pain Score 1

时间窗: At time of speculum placement for procedure

Scale of 0-10 on a self-reported pain score

Visual Analogue Scale Pain Score 2

时间窗: At start of cervical manipulation

Scale of 0-10 on a self-reported pain score

次要结局

未报告次要终点

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验