2024-512728-12-00招募中4 期
A randomized clinical trial to compare topical lidocaine-prilocaine cream (Emla) versus 2% lidocaine infiltration to first-degree perineal tears repair
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年7月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The values of the Visual Analogue Scale (VAS) of pain modified according to how they express women.
研究概览
简要总结
Compare the efficacy of injected versus topical lidocaine (EMLA) administration in women with first-degree perineal tear to evaluate pain, both in administration of the anesthetic as well as in the repair of perineal tissue and in the two hours after delivery.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single eutocic delivery.
- •Gestational age greater than or equal to 37 weeks
- •Presence of first degree laceration/tear requiring suturing
- •Postpartum woman of age greater than or equal to 18 years
排除标准
- •Administration of epidural analgesia.
- •Adverse reactions to any local anesthetic in the past
- •Infection at the site of anesthetic administration.
- •Heart, kidney or liver disease
- •Denial of participation in the study
- •Language barrier. Woman with cognitive deficit or any other mental, physical or social situation that makes it difficult understanding of the study
- •Woman with cognitive deficit or any other mental, physical or social situation that makes understanding the study difficult.
结局指标
主要结局
The values of the Visual Analogue Scale (VAS) of pain modified according to how they express women.
The values of the Visual Analogue Scale (VAS) of pain modified according to how they express women.
次要结局
- Characteristics of the tear: location.
- Characteristics of childbirth and postpartum: onset of labor, use of alternative therapies to pain management and performing uninterrupted skin-to-skin for the two hours postpartum (except when the newborn is weighed).
- Characteristics of the newborn: weight and sex.
- Characteristics of women: parity and age.
研究者
Eva Vilar Yebra y Andrea Aparicio Sanz
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
研究点 (1)
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